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

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.

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.

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