Effect of Luteal Progesterone Support on Pregnancy Rates... | NCT02510534

Studies
Effect of Luteal Progesterone Support on Pregnancy Rates With Combined Clomid/ Gonadotropin & IUI

NCT02510534

Sponsor

Northwest Center for Infertility and Reproductive Endocrinology

Status

Terminated

Last Update Posted

Sep 23, 2016Estimated

Enrollment

520Actual

Phase

Phase 1

Conditions

Pregnancy

Interventions

Menopur 150 international units
Endometrin 100 mg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

unable to enroll participants who meet the criteria

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Jul 24, 2015

First Submission Date that Met QC Criteria

Jul 26, 2015

First Posted Date

Jul 29, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2016

Last Update Posted Date

Sep 23, 2016Estimated

Name	Class
Ferring Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.

Detailed Description

Patients will be randomized in a treatment arm or control arm. The treatment arm receives the luteal progesterone support and the control arm does not. Each arm will have 260 patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

520Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	This arm receives Menopur 150 international units x 1 dose	Drug: Menopur 150 international units
Treatment	Active Comparator	This arm receives Menopur 150 international units x 1 dose and Endometrin 100mg twice a day x 14 days	Drug: Menopur 150 international units Drug: Endometrin 100 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Menopur 150 international units	Drug	Menopur 150 international units given x 1 dose	Control Treatment

Measure	Description	Time Frame
Effect on Pregnancy rate measured by detectable embryonic cardiac activity		10 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-37
BMI 19-34 kg/m2
Day 2-3 Follicle stimulating hormone (FSH) less than 10IU/mL
Estradiol (E2) less than 80 pg/mL
Anti-mullerian hormone (AMH) more than 1.5 ng/mL; or antral follicle count (AFC) up to 10
Two patent fallopian tubes confirmed by hysterosalpingogram (HSG) or chromopertubation
Normal uterine cavity confirmed by HSG, saline sonohysterogram (SIS) or hysteroscopy

Exclusion Criteria:

Severe male factor (total count less than 10 million sperm)
Systemic diseases not limited to diabetes
Pregnancy within 3 months
More than 1 prior cycle of gonadotropin treatment
Any ovarian cyst >15mm that has persisted for > 1 month
Endometrioma and/or Endometriosis-stage III or IV
Submucosal uterine fibroids; untreated endometrial polyps >1 cm;abnormal reproductive tract bleeding
Intolerance or allergy to study drug
Substance abuse (including alcohol and tobacco)
History of chemotherapy (except for gestational conditions) or radiotherapy
Minors and those adults not capable of consenting on their own

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

37 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Daniel Christie, MD	IVF FL	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Ivf Florida		Margate	Florida	33063	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006062	Gonadotropins
D011374	Progesterone

Ancestor Terms

ID	Term
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D011282	Pregnenediones

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