NCT03876145

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
Last Updated

April 20, 2021

Status Verified

February 1, 2019

Enrollment Period

2.5 years

First QC Date

February 25, 2019

Last Update Submit

April 18, 2021

Conditions

Polycystic Ovary SyndromeOvarian Hyperstimulation Syndrome

Outcome Measures

Primary Outcomes (3)

  • 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]).

  • Implantation rate

    The ratio of total number of observed gestational sacs to total number of transferred embryos.

    4 weeks after embryo transfer

  • Clinical pregnancy rate

    The observation of gestational sac with heart beat by using trans-vaginal ultrasound.

    4 weeks after embryo transfer

Secondary Outcomes (3)

  • ovarian hyper stimulation syndrome (OHSS) rate

    Up to approximately 2 month after oocyte pick-up (34-36 hours after hCG administration [approximately Stimulation Day 10]).

  • Total number of retrieved oocytes

    Day of oocyte pick-up, 34-36 hours after human curionic gonadotropin (hCG) administration (approximately Stimulation Day 10).

  • Quality of retrieved oocytes

    Day of oocyte pick-up, 34-36 hours after hCG administration (approximately Stimulation Day 10).

Study Arms (4)

Minimal ovarian stimulation with rec-FSH

EXPERIMENTAL

The group of minimal ovarian stimulation that will receive 100 mg clomiphene citrate every day from Day 3 to Day 7 of the menstrual cycle and then will be treated with 150 International Unit (IU) Gonal-f (Follitropin alfa, Merck Serono, Germany) after the seventh day.

Other: Minimal ovarian stimulation

Minimal ovarian stimulation with HMG

EXPERIMENTAL

The group of minimal ovarian stimulation that will receive 100 mg clomiphene citrate every day from Day 3 to Day 7 of the menstrual cycle and then will be treated with 150 IU Merional (Highly Purified Menotropin، IBSA، Switzerland) after the seventh day.

Other: Minimal ovarian stimulation

Mild ovarian stimulation with rec-FSH

NO INTERVENTION

The group of mild ovarian stimulation that will receive 150 IU Gonal-f (Follitropin alfa, Merck Serono, Germany) daily from Day 3 of the menstrual cycle.

Mild ovarian stimulation with HMG

NO INTERVENTION

The group of mild ovarian stimulation that will receive 150 IU Merional (Highly Purified Menotropin، IBSA، Switzerland) daily from Day 3 of the menstrual cycle.

Interventions

Minimal ovarian stimulationOTHER

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.

Minimal ovarian stimulation with HMGMinimal ovarian stimulation with rec-FSH

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile women with polycystic ovary syndrome based on Rotterdam criterion
  • \<Age\<38
  • BMI\<30
  • Non recurrent miscarriage
  • Non endocrine, hematologic and autoimmune disorders
  • Non chromosomal and genetic abnormalities
  • Non uterine anomalies, surgical history, endometriosis, adenomyosis, hydrosalpinx, uterine fibroids
  • Non azoospermia

You may not qualify if:

  • \. Patient's tendency for withdrawal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, 16635-148, Iran

Location

Related Publications (1)

  • Yahyaei A, Vesali S, Ghaffari F. Introduce an optimal method of ovarian stimulation in the polycystic ovarian syndrome affected: a randomized controlled trial. BMC Womens Health. 2023 Jun 20;23(1):323. doi: 10.1186/s12905-023-02473-2.

    PMID: 37340371DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeOvarian Hyperstimulation Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Firoozeh Ghaffari, M.D.

    Department of Endocrinology and Female Infertility, ACECR, Tehran, Iran.

    STUDY DIRECTOR

  • Azar Yahyaei, M.Sc.

    Department of Endocrinology and Female Infertility, ACECR, Tehran, Iran.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 15, 2019

Study Start

November 12, 2016

Primary Completion

May 5, 2019

Study Completion

November 20, 2020

Last Updated

April 20, 2021

Record last verified: 2019-02

Locations

IR(1)