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

Pregnancy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02510534
• Other study ID #: IVFFL001v2
• Status: Terminated
• Phase: Phase 1
• First received: July 24, 2015
• Last updated: September 22, 2016
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Northwest Center for Infertility and Reproductive Endocrinology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 520
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Menopur 150 international units
Menopur 150 international units given x 1 dose
• Endometrin 100 mg
Endometrin 100mg twice daily x 14 days

Locations

Country	Name	City	State
United States	Ivf Florida	Margate	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Northwest Center for Infertility and Reproductive Endocrinology	Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on Pregnancy rate measured by detectable embryonic cardiac activity		10 months	No