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

Information source: Northwest Center for Infertility and Reproductive Endocrinology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy

Intervention: Menopur 150 international units (Drug); Endometrin 100 mg (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Northwest Center for Infertility and Reproductive Endocrinology

Official(s) and/or principal investigator(s):
Daniel Christie, MD, Principal Investigator, Affiliation: IVF FL

Overall contact:
Daniel Christie, MD, Phone: 954-247-6200

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.

Clinical Details

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.

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

Primary outcome: Effect on Pregnancy rate measured by detectable embryonic cardiac activity

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 37 Years. Gender(s): Female.

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

Locations and Contacts

Daniel Christie, MD, Phone: 954-247-6200

Ivf Florida, Margate, Florida 33063, United States; Recruiting
Susan Sciandra, BSN,RN, Phone: 954-247-6200, Ext: 6258, Email: susan.sciandra@integramed.com
Daniel Christie, MD, Phone: 954-247-6200
Daniel Christie, MD, Principal Investigator
Additional Information

Starting date: July 2015
Last updated: July 26, 2015

Page last updated: August 23, 2015

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