Effect of Progestin-Induced Withdrawal Bleed on Ovulation Induction Cycles With Clomiphene Citrate

NCT01966575 | Withdrawn Phase 4

• 1 other identifier: H13-02187
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Women with polycystic ovary syndrome (PCOS) can suffer from infertility because they do not produce an egg each month, resulting in irregular periods. As a result, these women often need a medication called clomiphene citrate (clomiphene) to induce ovulation. A traditional 'clomiphene protocol' begins with a short course of progestin treatment to bring on a period (termed a 'withdrawal bleed') before starting the clomiphene medication. Newer evidence, however, has suggested that this progestin-induced shedding of the uterine lining (i.e., withdrawal bleed) may decrease the chances of pregnancy. The purpose of our study is to determine whether withdrawal bleeding has an impact on pregnancy rates for patients with PCOS undergoing a clomiphene cycle. It is hypothesized that patients who undergo ovulation induction with clomiphene citrate without prior endometrial shedding will have higher clinical pregnancy rates than those who begin with a progestin-induced withdrawal bleed.

Conditions

Polycystic Ovary Syndrome; Infertility

Keywords

Polycystic ovary syndrome; Progestin; Endometrial shedding; Ovulation induction cycles; Clomiphene citrate; Clinical pregnancy rate

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate per ovulation

  clinical pregnancy rate (gestational sac seen on ultrasound approximately 6-7 weeks after starting clomiphene) per ovulation

  6 weeks after starting clomiphene

Secondary Outcomes (6)

• cumulative pregnancy rate

  assessed 9 months after the ovulation induction cycles

• ovulation rate

  assessed 1 month after each induced ovulation cycle

• ongoing pregnancy rate

  assessed 12 weeks after clinical pregnancy is acheived

• miscarriage rate

  Assessed 4 months after clinical pregnancy acheived

• multiple pregnancy rate

  Assessed 4 months after clinical pregnancy acheived

Study Arms (2)

No withdrawal bleed

EXPERIMENTAL

No progestin prior to ovulation induction with clomiphene citrate

Drug: Progestin

Withdrawal Bleed

NO INTERVENTION

Progestin prior to beginning ovulation induction with clomiphene citrate (standard care)

Interventions

Progestin DRUG

The experimental group will have no progestin prior to ovulation induction with clomiphene citrate, while the comparison group will have progestin medication prior to ovulation induction with clomiphene citrate, as per usual care.

Also known as: medroxyprogesterone acetate (MPA), i.e. Provera

No withdrawal bleed

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Polycystic ovary syndrome (Rotterdam 2003 Consensus Criteria) and a diagnosis of anovulatory infertility
• Age 18-38 years
• At least 1 patent fallopian tube (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
• Normal semen analysis (total motile sperm count \>20million/ml)
• Normal uterine cavity (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
• Undergoing ovulation-induction with clomiphene citrate without intra-uterine insemination (IUI)

You may not qualify if:

• Body mass index (BMI) \< 17 kg/m2 or \> 40 kg/m2
• Prior treatment with clomiphene citrate
• Presence of a hydrosalpinx (as seen on ultrasound, hysterosalpingogram, hydrotubation or hysterosonogram)
• Those with systemic disease such as diabetes mellitus, uncontrolled thyroid disease, systemic lupus erythematosus and antiphospholipid antibody syndrome
• Any other cause of infertility other than anovulation

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Pacific Centre for Reproductive Medicine

Burnaby, British Columbia, V5G 4X7, Canada

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility

Interventions

Progestins; Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jon Havelock, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: October 21, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 6, 2014

Record last verified: 2014-11

Locations

CA (1)