Trial · NCT00827983

Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

NCT00827983, Phase 3, Completed, IBSA Institut Biochimique SA; results first posted 2012-12-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF). Trials, record NCT00827983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00827983

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)
NCT number: NCT00827983
Status: Completed
Phases: Phase 3
Enrollment: 683 participants, actual
Lead sponsor: IBSA Institut Biochimique SA
Conditions: In Vitro Fertilization
Interventions: Progesterone, Progesterone
First posted: 2009-01-23
Last updated: 2013-01-31
Results first posted: 2012-12-26
Limitations and caveats: no special limitations of the trial were detected.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Ongoing Pregnancy Rate at the End of the Study	10 weeks after treatment start
Secondary	Delivery Rate and Live Birth Rate	nearly 9 month after treatment start
Secondary	Implantation Rate	Four to five weeks after oocytes retrieval	Implantation rate was defined as the mean of the total number of gestational sacs seen divided by the total number of embryos transferred. Values are reported as a percentage.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Ongoing Pregnancy Rate at the End of the Study	10 weeks after treatment start	ITT population was analysed (i.e. all the randomised patients)	percentage of randomized patient	NUMBER
SECONDARY	Delivery Rate and Live Birth Rate	nearly 9 month after treatment start	all the randomised patients were included in the analysis	percentage of randomised patients	NUMBER
SECONDARY	Implantation Rate	Four to five weeks after oocytes retrieval	All the patients who had at least one embryo transferred	percentage of embryos transferred	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Ongoing Pregnancy Rate at the End of the Study	Progesterone SC	27.4	-9.9% to ?	percentage of randomized patient
Ongoing Pregnancy Rate at the End of the Study	Progesterone Vaginal Gel	30.5		percentage of randomized patient
Delivery Rate and Live Birth Rate	Progesterone SC	26.8		percentage of randomised patients
Delivery Rate and Live Birth Rate	Progesterone Vaginal Gel	29.9		percentage of randomised patients
Implantation Rate	Progesterone SC	22.6	Standard Deviation 35.0	percentage of embryos transferred
Implantation Rate	Progesterone Vaginal Gel	23.1	Standard Deviation 33.1	percentage of embryos transferred

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Progesterone SC	339
Overall Study	STARTED	Progesterone Vaginal Gel	344
Overall Study	COMPLETED	Progesterone SC	321
Overall Study	COMPLETED	Progesterone Vaginal Gel	328
Overall Study	NOT COMPLETED	Progesterone SC	18
Overall Study	NOT COMPLETED	Progesterone Vaginal Gel	16

Source ClinicalTrials.gov

Adverse events52

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	Abdominal distension	Gastrointestinal disorders	Progesterone SC	22	338	34
other	Abdominal distension	Gastrointestinal disorders	Progesterone Vaginal Gel	26	344	35
other	Abdominal pain	Gastrointestinal disorders	Progesterone SC	19	338	33
other	Abdominal pain	Gastrointestinal disorders	Progesterone Vaginal Gel	22	344	33
other	Nausea	Gastrointestinal disorders	Progesterone SC	17	338	26
other	Nausea	Gastrointestinal disorders	Progesterone Vaginal Gel	16	344	34
other	Headache	Nervous system disorders	Progesterone SC	18	338	29
other	Headache	Nervous system disorders	Progesterone Vaginal Gel	17	344	20
other	Breast tenderness	Respiratory, thoracic and mediastinal disorders	Progesterone SC	23	338	34
other	Breast tenderness	Respiratory, thoracic and mediastinal disorders	Progesterone Vaginal Gel	21	344	22

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Progesterone SC
Total, all-cause mortality	Progesterone Vaginal Gel
Total, other adverse events	Progesterone SC	168	338
Total, other adverse events	Progesterone Vaginal Gel	157	344
Total, serious adverse events	Progesterone SC	14	338
Total, serious adverse events	Progesterone Vaginal Gel	20	344

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24140033	DERIVED	PubMed
30895243	DERIVED	PubMed

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Progesterone SC vs Progesterone Vaginal Gel: serious adverse events

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00827983

GET https://conductscience.org/api/trials/v1/NCT00827983/events?page=2

API reference For AI assistants