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

Phase 1TerminatedNCT02510534

Northwest Center for Infertility and Reproductive Endocrinology520 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

520

Conditions

Pregnancy

Interventions

Menopur 150 international unitsDRUG

Menopur 150 international units given x 1 dose

Endometrin 100 mgDRUG

Endometrin 100mg twice daily x 14 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 37 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ivf Florida

Margate, Florida, United States

Outcomes

Primary Outcomes

Effect on Pregnancy rate measured by detectable embryonic cardiac activity

Time frame: 10 months

Data from ClinicalTrials.gov

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