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

Northwest Center for Infertility and Reproductive Endocrinology

Status and phase: Terminated; Phase 1

Conditions: Pregnancy

Treatments: Drug: Endometrin 100 mg; Drug: Menopur 150 international units

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02510534

IVFFL001v2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 520 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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520 participants in 2 patient groups

Control

Active Comparator group

Description:

This arm receives Menopur 150 international units x 1 dose

Treatment:

Drug: Menopur 150 international units

Treatment

Active Comparator group

Description:

This arm receives Menopur 150 international units x 1 dose and Endometrin 100mg twice a day x 14 days

Treatment:

Drug: Menopur 150 international units

Drug: Endometrin 100 mg