Know Cancer

or
forgot password

Optimizing Fertility Treatment in Women With Polycystic Ovary Syndrome (PCOS) Using the Clomiphene Citrate Fast-Track Protocol: a Randomized Controlled Trial


N/A
18 Years
35 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome, Infertility

Thank you

Trial Information

Optimizing Fertility Treatment in Women With Polycystic Ovary Syndrome (PCOS) Using the Clomiphene Citrate Fast-Track Protocol: a Randomized Controlled Trial

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical pregnancy confirmed by pelvic ultrasound

Outcome Time Frame:

Within 3 weeks of a positive pregnancy test

Safety Issue:

No

Principal Investigator

Jani Jensen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

12-006213

NCT ID:

NCT01718444

Start Date:

October 2012

Completion Date:

December 2015

Related Keywords:

  • Polycystic Ovary Syndrome
  • Infertility
  • PCOS
  • Polycystic ovary syndrome
  • Infertility
  • Anovulation
  • Clomiphene citrate
  • Clomid
  • Progestin
  • Infertility
  • Polycystic Ovary Syndrome

Name

Location

Mayo Clinic in RochesterRochester, Minnesota  55905