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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Jani Jensen, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Jani Jensen, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

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