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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Menopur 150 international units
* Drug: Endometrin 100 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>This arm receives Menopur 150 international units x 1 dose | Drug: Menopur 150 international units<br>* Menopur 150 international units given x 1 dose<br>* Other names: Gonadotropin;|
| Active Comparator: Treatment<br>This arm receives Menopur 150 international units x 1 dose and Endometrin 100mg twice a day x 14 days | Drug: Menopur 150 international units<br>* Menopur 150 international units given x 1 dose<br>* Other names: Gonadotropin;Drug: Endometrin 100 mg<br>* Endometrin 100mg twice daily x 14 days<br>* Other names: Progesterone;|

What is the study measuring?
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Primary Outcome Measures

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