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

NCT02510534 | Terminated Phase 1 DMC

• 1 other identifier: IVFFL001v2
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Effect on Pregnancy rate measured by detectable embryonic cardiac activity

  10 months

Study Arms (2)

Control

ACTIVE COMPARATOR

This arm receives Menopur 150 international units x 1 dose

Drug: Menopur 150 international units

Treatment

ACTIVE COMPARATOR

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

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

Interventions

Menopur 150 international units DRUG

Menopur 150 international units given x 1 dose

Also known as: Gonadotropin

Control; Treatment

Endometrin 100 mg DRUG

Endometrin 100mg twice daily x 14 days

Also known as: Progesterone

Treatment

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwest Center for Infertility and Reproductive Endocrinology: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Ivf Florida

Margate, Florida, 33063, United States

Location

MeSH Terms

Interventions

Gonadotropins; Progesterone

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Daniel Christie, MD

  IVF FL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: July 29, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

US (1)