Trial · NCT00828191

Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)

NCT00828191, 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 Tablets for Luteal Phase Support in In Vitro Fertilization (IVF). Trials, record NCT00828191. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00828191

On this page

Trial

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

Title: Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)
NCT number: NCT00828191
Status: Completed
Phases: Phase 3
Enrollment: 800 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 limitations of the trial reported.

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	10 weeks after treatment start
Secondary	Implantation Rate	4-5 weeks after treatment start	Implantation rate was defined as the number of gestational sacs divided by the number of embryos transferred (%). This value was calculated for all the patients who had at least one embryo transferred.
Secondary	Delivery Rate	nearly 9 months after treatment start

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	10 weeks after treatment start	All randomized patients were included in the analysis	percentage of randomized patients	NUMBER
SECONDARY	Implantation Rate	4-5 weeks after treatment start	Patient who had at least one embryo transferred.	percentage of embryos transferred	MEAN
SECONDARY	Delivery Rate	nearly 9 months after treatment start	All randomized patients	percentage of randomized patients	NUMBER

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	Progesterone SC	40.8		percentage of randomized patients
Ongoing Pregnancy Rate	Progesterone Tablets	43.3		percentage of randomized patients
Implantation Rate	Progesterone SC	33.2	Standard Deviation 42.0	percentage of embryos transferred
Implantation Rate	Progesterone Tablets	35.1	Standard Deviation 40.9	percentage of embryos transferred
Delivery Rate	Progesterone SC	40.5		percentage of randomized patients
Delivery Rate	Progesterone Tablets	42.5		percentage of randomized patients

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	400
Overall Study	STARTED	Progesterone Tablets	400
Overall Study	COMPLETED	Progesterone SC	392
Overall Study	COMPLETED	Progesterone Tablets	390
Overall Study	NOT COMPLETED	Progesterone SC	8
Overall Study	NOT COMPLETED	Progesterone Tablets	10

Source ClinicalTrials.gov

Adverse events16

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	Injection site bruising	General disorders	Progesterone SC	37	400	38
other	Injection site bruising	General disorders	Progesterone Tablets	0	400	0
other	Injection site discomfort	General disorders	Progesterone SC	57	400	68
other	Injection site discomfort	General disorders	Progesterone Tablets	0	400	0
other	Vaginal discharge	General disorders	Progesterone SC	0	400	0
other	Vaginal discharge	General disorders	Progesterone Tablets	50	400	50
other	Abdominal discomfort	Gastrointestinal disorders	Progesterone SC	21	400	25
other	Abdominal discomfort	Gastrointestinal disorders	Progesterone Tablets	28	400	35
other	Constipation	Gastrointestinal disorders	Progesterone SC	12	400	13
other	Constipation	Gastrointestinal disorders	Progesterone Tablets	23	400	23

1 to 10 of 16Source ClinicalTrials.gov

See all 16 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 Tablets
Total, other adverse events	Progesterone SC	156	400
Total, other adverse events	Progesterone Tablets	161	400
Total, serious adverse events	Progesterone SC	0	400
Total, serious adverse events	Progesterone Tablets	0	400

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25100106	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 Tablets: 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/NCT00828191

GET https://conductscience.org/api/trials/v1/NCT00828191/registered

API reference For AI assistants