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

NCT01718444 | Terminated Results

• 1 other identifier: 2014-1070
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Infertility

Keywords

PCOS; Polycystic ovary syndrome; Infertility; Anovulation; Clomiphene citrate; Clomid; Progestin; Provera; Progesterone; Endometrial shedding

Outcome Measures

Primary Outcomes (1)

• Live Birth

  Delivery of a viable infant after 24 weeks of pregnancy

  Within 36 weeks of a positive pregnancy test

Study Arms (2)

Group A (No PIES)

EXPERIMENTAL

Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course. * CC 50 mg oral for 5 days ("Days 3-7") * If no ovulation, CC 100 mg for 5 days ("Days 12-16") * If no ovulation, CC 150 mg for 5 days ("Day 21-25") * Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles

Drug: Clomiphene Citrate

Group B (PIES Group)

ACTIVE COMPARATOR

Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC) * Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES) * CC 50 mg oral for 5 days (Day 3-7) * If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses * If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days * Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles

Drug: Progestin; Drug: Clomiphene Citrate

Interventions

Progestin DRUG

Also known as: Provera, Medroxyprogesterone acetate

Group B (PIES Group)

Clomiphene Citrate DRUG

Also known as: Clomid

Group A (No PIES); Group B (PIES Group)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility; Anovulation

Interventions

Progestins; Medroxyprogesterone Acetate; Clomiphene

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; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available.

Results Point of Contact

• Title: Albert Asante, MD MPH
• Organization: UIC

akdasante@yahoo.com

3123552634

Study Officials

• Albert Asante, MD, MPH

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics-Gynecology, Consultant in Reproductive Endocrinology and Infertility

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 31, 2012
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 29, 2020
• Results First Posted: September 29, 2020

Record last verified: 2020-09

Locations

US (1)