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Clomiphene Citrate Fast-Track Protocol for Fertility Treatment in Women With PCOS

This study is currently recruiting participants.
Verified May 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Jani Jensen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01718444
First received: October 19, 2012
Last updated: May 3, 2013
Last verified: May 2013
History of Changes
  Purpose

Women with polycystic ovary syndrome (PCOS) have traditionally been treated for infertility by using progestin for a withdrawal bleed (aka endometrial shedding) before clomiphene citrate (CC) is administered to induce ovulation.

Recent evidence suggests that this approach (the traditional CC protocol) may be associated with decreased pregnancy and live birth rates, compared to the "fast track" CC protocol (in which no progestin is used).

The investigators are performing the first randomized controlled trial to find out if skipping the use of progestin (fast track CC protocol) during fertility therapy of anovulatory PCOS women leads to improved pregnancy and live birth rates compared to the traditional CC protocol.


Condition Intervention
Polycystic Ovary Syndrome
Infertility
 Drug: Progestin
Drug: Clomiphene Citrate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimizing Fertility Treatment in Women With Polycystic Ovary Syndrome (PCOS) Using the Clomiphene Citrate Fast-Track Protocol: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Clinical pregnancy confirmed by pelvic ultrasound [ Time Frame: Within 3 weeks of a positive pregnancy test ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first ovulation [ Time Frame: Within 3 months of start of CC ] [ Designated as safety issue: No ]
  • Time to clinical pregnancy [ Time Frame: Within 6 months of start of CC ] [ Designated as safety issue: No ]
  • Live birth [ Time Frame: Delivery after 24 weeks of pregnancy ] [ Designated as safety issue: No ]

Estimated Enrollment: 178
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clomiphene Citrate Fast-Track Protocol

Subjects randomized to this group will be managed using the Clomiphene Citrate (Clomid) fast-track protocol and will receive Clomid without using Progestin throughout their treatment course.

  • Clomid 50 mg oral for 5 days (Day 3-7)
  • If no ovulation, Clomid 100 mg for 5 days (Day 12-16)
  • If no ovulation, Clomid 150 mg for 5 days (Day 21-25)
 Drug: Clomiphene Citrate
Other Names:
  • Clomid
  • Clomiphene citrate
Active Comparator: Traditional Clomiphene Citrate Protocol

Women randomized to this group will receive Clomiphene Citrate (Clomid) using a traditional incremental-dose protocol, with Progestin given to induce a withdrawal bleed before starting any doses of Clomid.

  • Progestin 10 mg oral for 10 days to induce a withdrawal bleed
  • Clomid 50 mg oral for 5 days (Day 3-7)
  • If no ovulation, Progestin 10 mg for 10 days to induce withdrawal bleed (Day 21-30) and Clomid 100 mg for 5 days (Day 36-40)
  • If no ovulation, Progestin 10 mg for 10 days to induce withdrawal bleed (Day 54-63) and Clomid 150 mg for 5 days (Day 69-73)
 Drug: Progestin
Other Name: Provera
Drug: Clomiphene Citrate
Other Names:
  • Clomid
  • Clomiphene citrate

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • Women ages 18 - 35, 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 < 12mm
  • 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 6 months is required
  • Negative beta hcg within past one month
  • Negative progesterone within past one month

Exclusion

  • BMI > 40
  • Regular menstrual cycles occurring less than 35 days apart
  • Evidence of other infertility factors such as endometriosis, tubal factor or male infertility
  • Prior unsuccessful Clomid 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
  • Abnormal TSH
  • Abnormal PRL
  • Partner with abnormal semen analysis (count < 15 million sperm /ml)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718444

Contacts
Contact: Maureen A Lemens, BSN 507-293-1487 lemens.maureen@mayo.edu
Contact: Albert Asante, MD, MPH 507-284-4520 asante.albert@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Maureen A Lemens, RN     507-293-1487     lemens.maureen@mayo.edu    
Principal Investigator: Jani R Jensen, M.D.            
Sub-Investigator: Albert Asante, M.B.B.Ch.            
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jani Jensen, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Jani Jensen, Assistant Professor of Obstetrics-Gynecology, Consultant in Reproductive Endocrinology and Infertility, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01718444     History of Changes
Other Study ID Numbers: 12-006213
Study First Received: October 19, 2012
Last Updated: May 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
PCOS
Polycystic ovary syndrome
Infertility
Anovulation
 Clomiphene citrate
Clomid
Progestin

Additional relevant MeSH terms:
Infertility
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Clomiphene
Progestins
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Hormones

ClinicalTrials.gov processed this record on May 21, 2013