Dual Ovarian Stimulation in the Same IVF/ICSI Cycles for Treatment of Poor Ovarian Responders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a prospective before \& after clinical trial to investigate the efficacy of double stimulations during both the follicular and luteal phases in patients with poor ovarian response undergoing IVF and intracytoplasmic sperm injection (ICSI) cycles.

The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan institute. The study is conducted according to the Declaration of Helsinki for medical research. All participants provide informed consent after counseling for infertility treatments and routine IVF/ICSI programs.

All the patients who diagnosed as poor ovarian responders (POR) based on the Bologna criteria are eligible for participation in this study. In order to define the poor response in IVF, at least two of the following three features must be present: (i) advanced maternal age or any other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian reserve test (ORT). Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT.

Stage one of treatment protocol First stimulation performs by Clomiphene citrate (Ovumid®, Iran Hormones Company) 25 mg/day with co-treatment of Letrozole (Letrofem®, Iran Hormones Company) 2.5 mg/day are given from cycle day 3 onwards. Letrozole is only given for 4 days and clomiphene citrate is continuously used before the trigger day. Patients start to inject human menopausal gonadotrophin (HMG) (Menopur®, Ferring, Switzerland) 150 IU every other day beginning on cycle day 6. When one or two dominant follicles (18 mm in diameter) observed, the final stage of oocyte maturation will be induced with triptorelin 100 μg (Decapeptyl®; Ferring GmbH, Germany) follows by ibuprofen 600 mg (Ibuprofen-Najo® , Coated Tablets, Najo Company, Iran) is used on the day of oocyte maturation triggering and the day after. After the first oocyte retrieval, human menopausal gonadotrophin and letrozole are administrated to stimulate follicle development, and oocyte retrieval will be carried out a second time when dominant follicles have matured. All highest-quality embryos (including grade 1 and grade 2, eight-cell blastomere embryos) will be cryopreserved by vitrification method on the third day after oocyte retrieval.

Stage two of treatment protocol:

Transvaginal ultrasound evaluation performs after oocyte retrieval to determine whether to continue the second ovarian stimulation. The criterion for continued stimulation is the presence of at least two antral follicles 2-8 mm in diameter. A total of 225 IU HMG (Menopur®, Ferring, Switzerland) and letrozole 2.5 mg (Letrofem®, Iran Hormones Company) is administered daily from the day of, or the day after, oocyte retrieval. The initial second stage follicular monitoring is conducted 5-7 days later, and then for follow up every 2-4 days, by using a transvaginal ultrasound evaluation, to record the number of developing follicles. Letrozole administration is discontinued when the dominant follicles reached diameters of 12 mm, given that large follicles have redundant LH and FSH receptors, and good response to exogenous hormone stimulations. Daily administration of medroxyprogesterone acetate 10 mg (Progestrone®, 5mg bid; Aboureihan, Iran) is added beginning on stimulation day 12 for cases in which post-ovulation follicle size is smaller than 14 mm in diameter and stimulation needed to continue for several more days. This performs to postpone menstruation and avoid oocyte retrieval during menstruation, to prevent the risk of infection from the procedure. When three dominant follicles reached diameters of 18 mm or one mature dominant follicle exceeded 20 mm, the final stage of oocyte maturation is induced again with triptorelin 100 μg (Decapeptyl®; Ferring GmbH, Germany) by injection. Again, ibuprofen 600 mg (Ibuprofen-Najo® , Coated Tablets, Najo Company, Iran) is used on the day of oocyte maturation triggering and the day after. Transvaginal ultrasound-guided oocyte retrieval was conducted 32-36 h after GnRH agonist administration. All retrieved oocytes were treated same as in the study stage one.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Different Luteal Phase Support Methods in Patients With Poor Ovarian Response

NCT02798653

Infertility

UNKNOWN PHASE3

Efficacy of Low Dose hCG on Oocyte Maturity in Poor Responder Women Undergoing Intracytoplasmic Sperm Injection

NCT01509833

Infertility

COMPLETED PHASE3

Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders

NCT06093984

Infertility

NOT_YET_RECRUITING NA

Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles

NCT04008966

Assisted Reproduction

COMPLETED PHASE4

Dual Ovarian Stimulation (Duostim) and Shanghai Protocols in Poor Ovarian Responders

NCT06199960

Assisted Reproductive Techniques

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results. The mean of total number of retrieved oocytes and embryos after the present protocol were compared with the mean of total number of retrieved oocytes and embryos at previous routine cycle.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

poor ovarian responder

The women with diagnose of poor ovarian responder after IVF/ICSI treatments underwent ovulation stimulation and egg collection in the same IVF/ ICSI cycle ( Shanghai protocol)

Group Type EXPERIMENTAL

Ovulation stimulation

Intervention Type DRUG

Double stimulation in 2 phases:

Phase I: Clomiphene citrate (Ovumid®) 25 mg/day with co-treatment of Letrozole (Letrofem®) 2.5 mg/day are given from cycle day 3 onwards. Letrozole (Letrofem®) 2.5 mg/day are given from cycle day 3 onwards. human menopausal gonadotrophin (HMG) Menopur®150 IU every other day beginning on cycle day 6. triptorelin (Decapeptyl®) 100 μg follows by ibuprofen 600 mg.

Phase 2:A total of 225 IU HMG(Decapeptyl®) and letrozole (Letrofem®) 2.5 mg is administered daily .Daily administration of medroxyprogesterone acetate (Progestrone®)10 mg. . the final stage of oocyte maturation is induced again with triptorelin (Decapeptyl®)100 μg by injection.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ovulation stimulation

Double stimulation in 2 phases:

Phase I: Clomiphene citrate (Ovumid®) 25 mg/day with co-treatment of Letrozole (Letrofem®) 2.5 mg/day are given from cycle day 3 onwards. Letrozole (Letrofem®) 2.5 mg/day are given from cycle day 3 onwards. human menopausal gonadotrophin (HMG) Menopur®150 IU every other day beginning on cycle day 6. triptorelin (Decapeptyl®) 100 μg follows by ibuprofen 600 mg.

Phase 2:A total of 225 IU HMG(Decapeptyl®) and letrozole (Letrofem®) 2.5 mg is administered daily .Daily administration of medroxyprogesterone acetate (Progestrone®)10 mg. . the final stage of oocyte maturation is induced again with triptorelin (Decapeptyl®)100 μg by injection.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Diagnosis of Poor ovarian response (POR), according to Bologna criteria:

the patients have at least two of the following criteria:

* age over 40 years;
* a history of ovarian surgery;
* previous treatment using conventional protocols that yielded less than three oocytes;
* antral follicle count of less than 5 on menstrual cycle day 2-3; and basal serum Follicle Stimulating Hormone ( FSH) concentration between 10 and 19 IU/l.

Exclusion Criteria

* ovarian failure including basal Follicle Stimulating Hormone ( FSH) above 20 IU/l or no antral follicle by ultrasound examination;
* Endometriosis grade 3 or higher;
* Any contraindications to ovarian stimulation treatment.

Minimum Eligible Age

40 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Tahereh Madani, MD

Role: STUDY_DIRECTOR

Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Mandana Hemmat, MD

Role: STUDY_DIRECTOR

Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

Arezoo Arabipoor, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.