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

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Northwest Center for Infertility and Reproductive Endocrinology
• Collaborator: Ferring Pharmaceuticals
• Treatments: Menotropins; Progesterone

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