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The Four Methods of Ovarian Stimulation in Patients With Polycystic Ovarian Syndrome

NCT03876145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-04-20

No results posted yet for this study

Summary

This study is a randomized controlled clinical trial to compare the pregnancy outcomes of mild and minimal stimulation in infertile women with polycystic ovarian syndrome. The study population consisted of all infertile women with polycystic ovary syndrome based on Rotterdam criteria who have not succeed to achieve fertility despite multiple treatments such as drug therapy, laparoscopic surgery, and the frequent failure of induction therapy using gonadotropins and are now candidate for in vitro fertilization (IVF) or intra cytoplasmic sperm injection (ICSI) in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.

Conditions

  • Polycystic Ovary Syndrome
  • Ovarian Hyperstimulation Syndrome

Interventions

OTHER

Minimal ovarian stimulation

After obtaining informed consent to participate in the study, the subjects will be randomly divided into the following 4 groups: The group of minimal ovarian stimulation with rec-FSH or HMG. The group of mild ovarian stimulation with rec-FSH or HMG. In all 4 experimental groups, after reaching at least three follicles the size of 12 millimeters (mm), daily administration of 0.25 milligram (mg) Cetrotide (antagonist GnRH) will be started and after reaching at least three follicles the size of 17 mm, 500 microgram Ovitrelle (recombinant Human curionic gonadotropin) will be prescribed. 36 hours later, ovulation process will be done. On the day of Ovitrelle administration, serum levels of estradiol and progesterone will be also evaluated. Based on the patient's condition and the quality of obtained oocytes and embryos, 2 embryos will be transferred.

Sponsors & Collaborators

  • Royan Institute

    lead OTHER_GOV

Principal Investigators

  • Firoozeh Ghaffari, M.D. · Department of Endocrinology and Female Infertility, ACECR, Tehran, Iran.

  • Azar Yahyaei, M.Sc. · Department of Endocrinology and Female Infertility, ACECR, Tehran, Iran.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-12
Primary Completion
2019-05-05
Completion
2020-11-20

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876145 on ClinicalTrials.gov