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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03876145
Other study ID # Royan-Female Infertility
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 12, 2016
Est. completion date November 20, 2020

Study information

Verified date February 2019
Source Royan Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Iran, Islamic Republic of Royan Institute Tehran

Sponsors (1)

Lead Sponsor Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fertilization rate The ratio of 2 pronuclear to total number of injected oocytes. 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after hCG administration [approximately Stimulation Day 10]).
Primary Implantation rate The ratio of total number of observed gestational sacs to total number of transferred embryos. 4 weeks after embryo transfer
Primary Clinical pregnancy rate The observation of gestational sac with heart beat by using trans-vaginal ultrasound. 4 weeks after embryo transfer
Secondary ovarian hyper stimulation syndrome (OHSS) rate Total number of cases with symptoms of ovarian hyper-stimulation syndrome. Up to approximately 2 month after oocyte pick-up (34-36 hours after hCG administration [approximately Stimulation Day 10]).
Secondary Total number of retrieved oocytes Total number of obtained oocytes which reported by embryologist. Day of oocyte pick-up, 34-36 hours after human curionic gonadotropin (hCG) administration (approximately Stimulation Day 10).
Secondary Quality of retrieved oocytes Total number of Meta-phase II oocytes which reported by embryologist. Day of oocyte pick-up, 34-36 hours after hCG administration (approximately Stimulation Day 10).
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