Effect of Luteal Progesterone Support on Pregnancy Rates With Combined Clomid/ Gonadotropin & IUI
- Conditions
- Pregnancy
- Interventions
- Registration Number
- NCT02510534
- Lead Sponsor
- Northwest Center for Infertility and Reproductive Endocrinology
- 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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 520
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Menopur 150 international units This arm receives Menopur 150 international units x 1 dose Treatment Menopur 150 international units This arm receives Menopur 150 international units x 1 dose and Endometrin 100mg twice a day x 14 days Treatment Endometrin 100 mg This arm receives Menopur 150 international units x 1 dose and Endometrin 100mg twice a day x 14 days
- Primary Outcome Measures
Name Time Method Effect on Pregnancy rate measured by detectable embryonic cardiac activity 10 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ivf Florida
🇺🇸Margate, Florida, United States