Clinical trial NCT01966575: Effect of Progestin-Induced Withdrawal Bleed on Ovulation Induction Cycles With Clomiphene Citrate
Official title: Effect of Progestin-Induced Endometrial Shedding on Ovulation Induction Cycles With Clomiphene Citrate: A Randomized Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Infertility
Keywords: Polycystic ovary syndrome
Progestin
Endometrial shedding
Ovulation induction cycles
Clomiphene citrate
Clinical pregnancy rate
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-10-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical pregnancy rate per ovulation
timeFrame: 6 weeks after starting clomiphene
Secondary outcomes:
measure: cumulative pregnancy rate
timeFrame: assessed 9 months after the ovulation induction cycles
measure: ovulation rate
timeFrame: assessed 1 month after each induced ovulation cycle
measure: ongoing pregnancy rate
timeFrame: assessed 12 weeks after clinical pregnancy is acheived
measure: miscarriage rate
timeFrame: Assessed 4 months after clinical pregnancy acheived
measure: multiple pregnancy rate
timeFrame: Assessed 4 months after clinical pregnancy acheived
measure: endometrial thickness
timeFrame: Assessed at 1 month after conception
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Pacific Centre for Reproductive Medicine
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jon Havelock, MD
role: PRINCIPAL_INVESTIGATOR
References: