Trial · NCT01850030

A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization

NCT01850030, Phase 3, Completed, Abbott; results first posted 2018-01-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization. Trials, record NCT01850030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01850030

On this page

Trial

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

Title: A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization
NCT number: NCT01850030
Status: Completed
Phases: Phase 3
Enrollment: 1,070 participants, actual
Lead sponsor: Abbott
Conditions: Female Infertility
Interventions: Dydrogesterone 30 mg, Micronized Progesterone 600 mg, Placebo progesterone, Placebo dydrogesterone
First posted: 2013-05-09
Last updated: 2018-01-02
Other registries' IDs: eudract:2012-002215-26
Results first posted: 2018-01-02

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants Being Pregnant as Measured by the Presence of Fetal Heart Beats at 12 Weeks´Gestation Using Transvaginal Ultrasound	12 weeks´ gestation (at visit 6)	Percentage of participants being pregnant as measured by the presence of fetal heart beats at 12 weeks´gestation using transvaginal ultrasound
Secondary	Percentage of Participants Being Pregnant as Measured by the Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer	Day 14 after embryo transfer	Percentage of participants being pregnant as measured by the positive biochemical pregnancy test on Day 14 after embryo transfer
Secondary	Percentage of Participants With a Successful Completion of Pregnancy	After delivery (about 9 months after IVF)	Incidence of live births and healthy newborns
Secondary	Gender of the Newborn	After delivery (about 9 months after IVF)	was recorded and collected for Newborn

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Percentage of Participants Being Pregnant as Measured by the Presence of Fetal Heart Beats at 12 Weeks´Gestation Using Transvaginal Ultrasound	12 weeks´ gestation (at visit 6)	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Being Pregnant as Measured by the Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer	Day 14 after embryo transfer	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With a Successful Completion of Pregnancy	After delivery (about 9 months after IVF)	percentage of participants	NUMBER
SECONDARY	Gender of the Newborn	After delivery (about 9 months after IVF)	number of newborns	NUMBER

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants Being Pregnant as Measured by the Presence of Fetal Heart Beats at 12 Weeks´Gestation Using Transvaginal Ultrasound	Dydrogesterone 30 mg		37.6	95% Confidence Interval 33.4 to 42.1	percentage of participants
Percentage of Participants Being Pregnant as Measured by the Presence of Fetal Heart Beats at 12 Weeks´Gestation Using Transvaginal Ultrasound	Micronized Progesterone 600 mg		33.1	95% Confidence Interval 28.9 to 37.6	percentage of participants
Percentage of Participants Being Pregnant as Measured by the Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer	Dydrogesterone 30 mg		47.1	95% Confidence Interval 42.6 to 51.6	percentage of participants
Percentage of Participants Being Pregnant as Measured by the Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer	Micronized Progesterone 600 mg		45.5	95% Confidence Interval 41.0 to 50.1	percentage of participants
Percentage of Participants With a Successful Completion of Pregnancy	Dydrogesterone 30 mg	Live birth rate	34.6	95% Confidence Interval 30.4 to 39.0	percentage of participants
Percentage of Participants With a Successful Completion of Pregnancy	Micronized Progesterone 600 mg	Live birth rate	29.8	95% Confidence Interval 25.7 to 34.1	percentage of participants
Percentage of Participants With a Successful Completion of Pregnancy	Dydrogesterone 30 mg	Healthy newborn rate	32	95% Confidence Interval 27.9 to 36.3	percentage of participants
Percentage of Participants With a Successful Completion of Pregnancy	Micronized Progesterone 600 mg	Healthy newborn rate	27.7	95% Confidence Interval 23.7 to 31.9	percentage of participants
Gender of the Newborn	Dydrogesterone 30 mg	Gender male	120		number of newborns
Gender of the Newborn	Micronized Progesterone 600 mg	Gender male	88		number of newborns

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Dydrogesterone 30 mg	520
Overall Study	STARTED	Micronized Progesterone 600 mg	511
Overall Study	COMPLETED	Dydrogesterone 30 mg	173
Overall Study	COMPLETED	Micronized Progesterone 600 mg	142
Overall Study	NOT COMPLETED	Dydrogesterone 30 mg	347
Overall Study	NOT COMPLETED	Micronized Progesterone 600 mg	369

Source ClinicalTrials.gov

Adverse events120

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	Vaginal haemorrhage	Reproductive system and breast disorders	Dydrogesterone 30 mg	61	518	75
other	Vaginal haemorrhage	Reproductive system and breast disorders	Micronized Progesterone 600 mg	45	511	53
other	Procedural pain	Injury, poisoning and procedural complications	Dydrogesterone 30 mg	38	518	39
other	Procedural pain	Injury, poisoning and procedural complications	Micronized Progesterone 600 mg	41	511	42
other	Nausea	Gastrointestinal disorders	Dydrogesterone 30 mg	44	518	46
other	Nausea	Gastrointestinal disorders	Micronized Progesterone 600 mg	26	511	27
other	Abdominal pain	Gastrointestinal disorders	Dydrogesterone 30 mg	24	518	25
other	Abdominal pain	Gastrointestinal disorders	Micronized Progesterone 600 mg	31	511	33
other	Headache	Nervous system disorders	Dydrogesterone 30 mg	27	518	31
other	Headache	Nervous system disorders	Micronized Progesterone 600 mg	32	511	36

1 to 10 of 120Source ClinicalTrials.gov

See all 120 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dydrogesterone 30 mg
Total, all-cause mortality	Micronized Progesterone 600 mg
Total, other adverse events	Dydrogesterone 30 mg	156	518
Total, other adverse events	Micronized Progesterone 600 mg	147	511
Total, serious adverse events	Dydrogesterone 30 mg	56	518
Total, serious adverse events	Micronized Progesterone 600 mg	68	511

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28333318	DERIVED

Source 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
Dydrogesterone 30 mg vs Micronized Progesterone 600 mg: 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/NCT01850030

GET https://conductscience.org/api/trials/v1/NCT01850030/events?page=2

API reference For AI assistants