Trial · NCT02432209

Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility

NCT02432209, Phase 3, Completed, Yale University; results first posted 2021-03-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility. Trials, record NCT02432209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02432209

On this page

Trial

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

Title: Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility
NCT number: NCT02432209
Status: Completed
Phases: Phase 3
Enrollment: 379 participants, actual
Lead sponsor: Yale University
Conditions: Infertility, Female
Interventions: Caloric Restriction, Orlistat, Moderate physical activity
First posted: 2015-05-04
Last updated: 2022-02-03
Results first posted: 2021-03-15

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Rate of Good Birth Outcomes	At time of birth, approximately 17 months into the study	Defined as a live birth of an infant born at ≥ 37 weeks, with a birth weight between 2500 and 4000g and without a major congenital anomaly
Secondary	Live Birth Rate	At time of birth, approximately 17 months into the study	All the live birth for the study
Secondary	Time to Pregnancy in Days	0-8 months	Days from randomization to the first known date of conception
Secondary	Pregnancy Loss Rate	After conception, 0-13 months into the study	Pregnancy loss (conception without a live birth) among those who achieved pregnancy
Secondary	Multiple Pregnancy Rate	After conception, 1-13 months into the study	Determined by number of multiple pregnancies / number of pregnancies
Secondary	Birth Weight in Grams	at time of birth, approximately 17 months into the study	Birth weight (grams) for infant delivered
Secondary	Mode of Delivery-Cesarean Section	At time of birth, approximately 17 months into the study	Babies by Cesarean Section/Number of participants who delivered baby

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Rate of Good Birth Outcomes	At time of birth, approximately 17 months into the study		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Live Birth Rate	At time of birth, approximately 17 months into the study		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Pregnancy in Days	0-8 months	For those who achieved pregnancy	days	MEDIAN
SECONDARY	Pregnancy Loss Rate	After conception, 0-13 months into the study	For those who achieved pregnancy	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Multiple Pregnancy Rate	After conception, 1-13 months into the study	For those with clinical pregnancy	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Birth Weight in Grams	at time of birth, approximately 17 months into the study	For the live-born infants	gram	MEDIAN
SECONDARY	Mode of Delivery-Cesarean Section	At time of birth, approximately 17 months into the study	For those who delivered baby(babies)	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Value	Spread	Units
Rate of Good Birth Outcomes	Intensive Lifestyle Mod. Intervention	23		Participants
Rate of Good Birth Outcomes	Standard Lifestyle Intervention	29		Participants
Live Birth Rate	Intensive Lifestyle Mod. Intervention	38		Participants
Live Birth Rate	Standard Lifestyle Intervention	42		Participants
Time to Pregnancy in Days	Intensive Lifestyle Mod. Intervention	160	Inter-Quartile Range 102 to 190	days
Time to Pregnancy in Days	Standard Lifestyle Intervention	163	Inter-Quartile Range 98.5 to 214	days
Pregnancy Loss Rate	Intensive Lifestyle Mod. Intervention	24		Participants
Pregnancy Loss Rate	Standard Lifestyle Intervention	14		Participants
Multiple Pregnancy Rate	Intensive Lifestyle Mod. Intervention	7		Participants
Multiple Pregnancy Rate	Standard Lifestyle Intervention	3		Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Intensive Lifestyle Mod. Intervention	188
Overall Study	STARTED	Standard Lifestyle Intervention	191
Overall Study	COMPLETED	Intensive Lifestyle Mod. Intervention	157
Overall Study	COMPLETED	Standard Lifestyle Intervention	151
Overall Study	NOT COMPLETED	Intensive Lifestyle Mod. Intervention	31
Overall Study	NOT COMPLETED	Standard Lifestyle Intervention	40

Source ClinicalTrials.gov

Adverse events74

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
other	Constipation	Cardiac disorders	Intensive Lifestyle Mod. Intervention	23	188
other	Constipation	Cardiac disorders	Standard Lifestyle Intervention	7	191
other	Diarrhea	General disorders	Intensive Lifestyle Mod. Intervention	35	188
other	Diarrhea	General disorders	Standard Lifestyle Intervention	9	191
other	Fever	General disorders	Intensive Lifestyle Mod. Intervention	5	188
other	Fever	General disorders	Standard Lifestyle Intervention	0	191
other	Flatulence	Gastrointestinal disorders	Intensive Lifestyle Mod. Intervention	33	188
other	Flatulence	Gastrointestinal disorders	Standard Lifestyle Intervention	2	191
other	Mood swings	General disorders	Intensive Lifestyle Mod. Intervention	2	188
other	Mood swings	General disorders	Standard Lifestyle Intervention	9	191

1 to 10 of 74Source ClinicalTrials.gov

See all 74 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intensive Lifestyle Mod. Intervention	0	188
Total, all-cause mortality	Standard Lifestyle Intervention	0	191
Total, other adverse events	Intensive Lifestyle Mod. Intervention	157	188
Total, other adverse events	Standard Lifestyle Intervention	157	191
Total, serious adverse events	Intensive Lifestyle Mod. Intervention	12	188
Total, serious adverse events	Standard Lifestyle Intervention	13	191

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35041662	DERIVED	PubMed
37719091	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 comparisons7

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

Comparison	Source
Intensive Lifestyle Mod. Intervention vs Standard Lifestyle Intervention: Rate of Good Birth Outcomes	Trial comparisons
Intensive Lifestyle Mod. Intervention vs Standard Lifestyle Intervention: Live Birth Rate	Trial comparisons
Intensive Lifestyle Mod. Intervention vs Standard Lifestyle Intervention: Pregnancy Loss Rate	Trial comparisons
Intensive Lifestyle Mod. Intervention vs Standard Lifestyle Intervention: Multiple Pregnancy Rate	Trial comparisons
Intensive Lifestyle Mod. Intervention vs Standard Lifestyle Intervention: Mode of Delivery-Cesarean Section	Trial comparisons
Intensive Lifestyle Mod. Intervention vs Standard Lifestyle Intervention: deaths from any cause	Trial comparisons
Intensive Lifestyle Mod. Intervention vs Standard Lifestyle Intervention: 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.

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/NCT02432209

GET https://conductscience.org/api/trials/v1/NCT02432209/events?page=2

API reference For AI assistants