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

September 22, 2016 updated by: Northwest Center for Infertility and Reproductive Endocrinology

A Prospective Randomized Trial to Study the Effect of Luteal Progesterone Support on Pregnancy Rates in Combined Clomiphene Citrate and Gonadotropin Ovulation Induction Protocol With Intrauterine Insemination.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

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.

Study Type

Interventional

Enrollment (Actual)

520

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Margate, Florida, United States, 33063
        • IVF Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
This arm receives Menopur 150 international units x 1 dose
Drug: Menopur 150 international units
Menopur 150 international units given x 1 dose
Other Names:
  • Gonadotropin
Active Comparator: Treatment
This arm receives Menopur 150 international units x 1 dose and Endometrin 100mg twice a day x 14 days
Drug: Menopur 150 international units
Menopur 150 international units given x 1 dose
Other Names:
  • Gonadotropin
Drug: Endometrin 100 mg
Endometrin 100mg twice daily x 14 days
Other Names:
  • Progesterone

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwest Center for Infertility and Reproductive Endocrinology

Collaborators

Ferring Pharmaceuticals

Investigators

  • Principal Investigator: Daniel Christie, MD, IVF FL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

July 26, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVFFL001v2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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