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

Infertility Clinical Trial

Official title:

Effect of Progestin-Induced Endometrial Shedding on Ovulation Induction Cycles With Clomiphene Citrate: A Randomized Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01966575
• Other study ID #: H13-02187
• Status: Withdrawn
• Phase: Phase 4
• First received: September 17, 2013
• Last updated: November 4, 2014
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovary Syndrome

Intervention

Drug:
• Progestin
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.

Locations

Country	Name	City	State
Canada	Pacific Centre for Reproductive Medicine	Burnaby	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	cumulative pregnancy rate	cumulative pregnancy rate	assessed 9 months after the ovulation induction cycles	No
Secondary	ovulation rate	ovulation rate (progesterone >10nmol/L per clomiphene cycle)	assessed 1 month after each induced ovulation cycle	No
Secondary	ongoing pregnancy rate	ongoing pregnancy rate (pregnancy with a fetal heartbeat >12 weeks gestational age)	assessed 12 weeks after clinical pregnancy is acheived	No
Secondary	miscarriage rate	miscarriage rate	Assessed 4 months after clinical pregnancy acheived	No
Secondary	multiple pregnancy rate	multiple pregnancy rate (twins and higher order multiples)	Assessed 4 months after clinical pregnancy acheived	No
Secondary	endometrial thickness	endometrial thickness (assessed via transvaginal ultrasound)	Assessed at 1 month after conception	No