Trial · NCT02310919
Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles
NCT02310919, Phase 3, Completed, University of California, San Francisco; results first posted 2022-04-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles. Trials, record NCT02310919. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02310919
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles
- NCT number
- NCT02310919
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 105 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Infertility
- Interventions
- Low dose hCG plus FSH co-trigger, Standard dose of hCG
- First posted
- 2014-12-08
- Last updated
- 2022-04-29
- Results first posted
- 2022-04-29
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Fertilization Proportion (i.e. Total Competent Proportion) | 2 days | The number of fertilized oocytes (2-pronuclei) after standard in vitro fertilization or intra-cytoplasmic sperm injection divided by the total number of oocytes retrieved as a measure of oocyte competence. |
| Secondary | Number of Oocytes Retrieved | 1 day | The total number of oocytes recovered at the oocyte retrieval. |
| Secondary | Number of MII Oocytes | 1 day | The number of metaphase 2 oocytes (MII) recovered which can only be calculated in patients that underwent intracytoplasmic sperm injection. |
| Secondary | Total Oocyte Maturity Rate | 1 day | Oocyte maturity rate was determined by the number of meta phase 2 (MII) oocytes divided by the number of oocytes retrieved. This outcome was only assessed in patients undergoing intracytoplasmic sperm injection (ICSI). |
| Secondary | Mature Oocyte Recovery Proportion | 1 day | Mature oocyte recovery proportion is defined as the number of MIIs divided by the total number of follicles greater or equal to 13mm in size on trigger day. |
| Secondary | ICSI Fertilization Rate | 2 days | ICSI fertilization rate was determined by the number of 2 pro-nuclei (2PN) divided by the number of MII oocytes. This was only assessed in patients undergoing ICSI. |
| Secondary | High Quality Cleavage-stage Embryos | 4 days | Good quality embryo development was compared between trigger groups by calculating the ratio of good quality embryos to the total number of cleavage-stage embryos. A good quality cleavage-stage embryo was defined by having a cell number of 7 to 10 and \<10% of cell fragmentation based on a modified Veeck's grading system. |
| Secondary | High Quality Blastocyst Embryos | 6 days | A high quality blastocyst was defined as grade 3 or higher expansion plus inner cell mass and trophectoderm grading of A or B based on Gardner's criteria. The number describes the degree of embryo expansion on a scale from 1-6. As the embryo expands, the degree of expansion increases. The first letter indicates on a scale from A to C (A being the highest) the quality of the inner cell mass. The second letter is also on a scale from A to C (A being the highest) and indicates the quality of the trophectoderm. |
| Secondary | Livebirth Rate From All Fresh Transfers | 10 months | Livebirth rate (LBR) was defined as a liveborn at the time of the analysis. Pregnancy outcomes were calculated for all fresh transfers. |
| Secondary | Bloating Score | about 16 days (varies by subject), accounts for the median length of IVF stimulation in this study being 11 days from baseline to 5 days post trigger | Change in bloating scores from day of baseline ultrasound to post-trigger day 5. The patient's clinical symptoms will be evaluated based on a bloating score reported by each patient on the day of ovulation trigger and then 5 days after the oocyte retrieval will be determined. The bloating score will range on a scale from 0-5. The number describes the degree of bloating and will increase as the degree of bloating increases. The bloating score will be determined as follows: 0 - No bloating 1. \- Mild bloating. Able to continue daily activities without discomfort. 2. \- Mild to moderate bloating. Able to continue daily activities but with mild discomfort. 3. \- Moderate bloating. Able to continue daily activities but with moderate discomfort. 4. \- Moderate to severe bloating. Difficulty performing daily activities. 5. \- Severe bloating. Abdomen feels very tense and unable to perform daily activities. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Fertilization Proportion (i.e. Total Competent Proportion) | 2 days | ratio | MEAN | |
| SECONDARY | Number of Oocytes Retrieved | 1 day | No outcome data for 1 participant that elected to convert to intrauterine insemination after trigger | oocytes | MEAN |
| SECONDARY | Number of MII Oocytes | 1 day | This parameter can only be calculated in patients that underwent oocyte stripping to undergo intracytoplasmic sperm injection for fertilization method. | MII oocytes | MEAN |
| SECONDARY | Total Oocyte Maturity Rate | 1 day | This parameter can only be calculated in patients that underwent oocyte stripping to undergo intracytoplasmic sperm injection for fertilization method. | ratio of MII oocytes | MEAN |
| SECONDARY | Mature Oocyte Recovery Proportion | 1 day | This parameter can only be calculated in patients that underwent oocyte stripping to undergo intracytoplasmic sperm injection for fertilization method. | ratio | MEAN |
| SECONDARY | ICSI Fertilization Rate | 2 days | This parameter can only be calculated in patients that were undergoing intracytoplasmic sperm injection for fertilization method. One participant the low dose hCG plus FSH co-trigger arm was not included in the analysis as they underwent oocyte cryopreservation instead as the male partner was unable to produce fresh sperm sample to fertilize the oocytes. | ratio of fertilized oocytes | MEAN |
| SECONDARY | High Quality Cleavage-stage Embryos | 4 days | No outcome data for 3 participants: 1) participant that elected to convert to intrauterine insemination after trigger; 2) participant that underwent oocyte cryopreservation due to male partner being unable to produce fresh sperm sample for fertilization; 3) cleavage-stage embryo quality was inadvertently not documented by the staff embryologist in one participant | ratio of good quality embryos | MEAN |
| SECONDARY | High Quality Blastocyst Embryos | 6 days | ratio of good quality embryos | MEAN | |
| SECONDARY | Livebirth Rate From All Fresh Transfers | 10 months | Only patients that underwent a fresh embryo transfer can be included in this analysis. Not all participants underwent fresh embryo transfers. | live births | NUMBER |
| SECONDARY | Bloating Score | about 16 days (varies by subject), accounts for the median length of IVF stimulation in this study being 11 days from baseline to 5 days post trigger | Only patients that answered this question on the study questionnaire could be included in this analysis. | score on a scale | MEDIAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Fertilization Proportion (i.e. Total Competent Proportion) | Low Dose hCG Plus FSH Co-trigger | 0.59 | Standard Error 0.029 | ratio | |
| Total Fertilization Proportion (i.e. Total Competent Proportion) | Standard Dose of hCG Alone | 0.65 | Standard Error 0.024 | ratio | |
| Number of Oocytes Retrieved | Low Dose hCG Plus FSH Co-trigger | 13.6 | Standard Error 0.84 | oocytes | |
| Number of Oocytes Retrieved | Standard Dose of hCG Alone | 16.1 | Standard Error 1.01 | oocytes | |
| Number of MII Oocytes | Low Dose hCG Plus FSH Co-trigger | 10.8 | Standard Error 0.74 | MII oocytes | |
| Number of MII Oocytes | Standard Dose of hCG Alone | 12.5 | Standard Error 0.81 | MII oocytes | |
| Total Oocyte Maturity Rate | Low Dose hCG Plus FSH Co-trigger | 0.75 | Standard Error 0.021 | ratio of MII oocytes | |
| Total Oocyte Maturity Rate | Standard Dose of hCG Alone | 0.77 | Standard Error 0.020 | ratio of MII oocytes | |
| Mature Oocyte Recovery Proportion | Low Dose hCG Plus FSH Co-trigger | 0.81 | Standard Error 0.032 | ratio | |
| Mature Oocyte Recovery Proportion | Standard Dose of hCG Alone | 0.92 | Standard Error 0.018 | ratio |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Dose hCG Plus FSH Co-trigger | 54 | |
| Overall Study | STARTED | Standard Dose of hCG Alone | 51 | |
| Overall Study | COMPLETED | Low Dose hCG Plus FSH Co-trigger | 54 | |
| Overall Study | COMPLETED | Standard Dose of hCG Alone | 51 | |
| Overall Study | NOT COMPLETED | Low Dose hCG Plus FSH Co-trigger | 0 | |
| Overall Study | NOT COMPLETED | Standard Dose of hCG Alone | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mild OHSS | Reproductive system and breast disorders | Low Dose hCG Plus FSH Co-trigger | 0 | 54 | |
| other | Mild OHSS | Reproductive system and breast disorders | Standard Dose of hCG Alone | 1 | 51 | 1 |
| serious | Severe OHSS | Reproductive system and breast disorders | Low Dose hCG Plus FSH Co-trigger | 0 | 54 | |
| serious | Severe OHSS | Reproductive system and breast disorders | Standard Dose of hCG Alone | 1 | 51 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose hCG Plus FSH Co-trigger | 0 | 54 |
| Total, all-cause mortality | Standard Dose of hCG Alone | 0 | 51 |
| Total, other adverse events | Low Dose hCG Plus FSH Co-trigger | 0 | 54 |
| Total, other adverse events | Standard Dose of hCG Alone | 1 | 51 |
| Total, serious adverse events | Low Dose hCG Plus FSH Co-trigger | 0 | 54 |
| Total, serious adverse events | Standard Dose of hCG Alone | 1 | 51 |
Source ClinicalTrials.gov
Papers15
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Low Dose hCG Plus FSH Co-trigger vs Standard Dose of hCG Alone: deaths from any cause | Trial comparisons |
| Low Dose hCG Plus FSH Co-trigger vs Standard Dose of hCG Alone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02310919
GET https://conductscience.org/api/trials/v1/NCT02310919/registered?page=2