Clinical trial NCT01718444: Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)
Official title: Optimizing Fertility Treatment in Women With Polycystic Ovary Syndrome (PCOS) - A Randomized Controlled Trial: The Role of Progestin-induced Endometrial Shedding in PCOS (PIES in PCOS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Infertility
Keywords: PCOS
Polycystic ovary syndrome
Infertility
Anovulation
Clomiphene citrate
Clomid
Progestin
Provera
Progesterone
Endometrial shedding
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Progestin-induced endometrial shedding (PIES) followed by clomiphene citrate is fertility treatment of choice in anovulatory women with polycystic ovary syndrome (PCOS). However, some preliminary data suggest that skipping PIES could result in a higher live birth rate. The investigators are performing the first randomized controlled trial to find out if skipping the use of progestin during fertility treatment of anovulatory PCOS women is associated with improved pregnancy and live birth rates compared to the traditional approach of using progestin prior to use of clomiphene citrate.

Detailed description: This is a prospective randomized trial of clomiphene citrate (CC) preceded by progestin-induced endometrial shedding (PIES) vs CC without PIES in the treatment of infertility in patients with PCOS, for up to 5 treatment cycles.

Participants will be randomized to receive either progestin followed by CC starting on day 3 of the induced menses, or CC without induced menses. Study participants will be monitored at regular 2 to 4 wks intervals for response to medication using ultrasound and hormonal parameters. The maximum dose of CC will not exceed 750 mg/cycle. Treatment will not exceed 5 ovulatory cycles. Participants who are resistant to 150 mg of CC will exit the study.

170 anovulatory PCOS women actively seeking pregnancy, aged 18 through 40 years will be enrolled and randomized in a 1:1 treatment ratio into the two study arms. Anovulation will be the only infertility factor in all patients.

Eligibility criteria: Inclusion

* Women aged 18 - 40, desiring pregnancy
* Established diagnosis of PCOS confirmed by the Rotterdam criteria
* Oligo or anovulatory, with menstrual cycles \> 35 days apart or less than 9 menstrual cycles per year
* Normal vaginal ultrasound with endometrial stripe \< 12 mm
* Normal thyroid stimulating hormone (TSH) within past one year
* Normal prolactin (PRL) within past one year
* For women with previous successful Clomid treatment, a washout period of at least 2 months is required

Exclusion

* Regular menstrual cycles occurring less than 35 days apart
* Evidence of other infertility factors such as endometriosis, tubal factor or male infertility
* Prior unsuccessful Clomiphene citrate ovulation cycles
* Abnormal vaginal ultrasound findings such as endometrial polyps, submucous myomas, synechiae
* Uterine anomaly such as unicornuate or bicornuate uterus
* Presence of hydrosalpinx
* Evidence of active endocrinopathy, such as thyroid disorder or hyperprolactinemia
* Partner with abnormal semen analysis (count \< 15 million sperm /ml)

Primary outcomes:
measure: Live Birth
timeFrame: Within 36 weeks of a positive pregnancy test
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Albert Asante, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: