Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)

• Status: Terminated
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Illinois at Chicago
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Medroxyprogesterone; Medroxyprogesterone Acetate; Progestins; Zuclomiphene

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)