Outcome of Three Controlled Ovarian Hyperstimulation Protocols in Poor Responding Infertility Patients

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

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-08-31

Brief Summary

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

There are different controlled ovarian hyperstimulation protocols utilized in infertility patients. In this study, our aim is to specifically compare three protocols in poor responding infertility patients.

Related Clinical Trials

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

Comparison of Recombinant Follicle Stimulating Hormone and the Combination of Recombinant Follicle Stimulating Hormone With Clomiphene Citrate in Stimulated Intrauterine Insemination Cycles

NCT05670795

Infertility Unexplained

RECRUITING NA

Comparison of Treatment Modalities in Poor Responders Undergoing IVF

NCT02158689

Poor Responders

COMPLETED NA

Pregnancy Outcomes of Patients Having NC-FET Regarding the Progesterone Levels

NCT05690360

Infertility

UNKNOWN

Letrozole Versus Hormonal Preparation in Frozen Cycles of PCOS Patients.

NCT05168865

Frozen Embryo Transfer Polycystic Ovarian Disease Letrozole +3 more

WITHDRAWN PHASE4

COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation

NCT02288143

Infertility

COMPLETED PHASE4

Detailed Description

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

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

RANDOMIZED

Intervention Model

PARALLEL

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.

Combined 450

Recombinant FSH 225IU/day and human menopausal gonadotropin (hMG) 225IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.

Group Type ACTIVE_COMPARATOR

FSH 225IU and hMG 225IU

Intervention Type DRUG

Combined 300

Recombinant FSH 150IU/day and human menopausal gonadotropin (hMG) 150IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.

Group Type ACTIVE_COMPARATOR

FSH 150IU and hMG 150IU

Intervention Type DRUG

Letrozole and hMG

Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day and human menopausal gonadotropin (hMG) 150IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.

Group Type ACTIVE_COMPARATOR

Letrozole 5mg and hMG 150IU

Intervention Type DRUG

Interventions

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

FSH 225IU and hMG 225IU

Intervention Type DRUG

FSH 150IU and hMG 150IU

Intervention Type DRUG

Letrozole 5mg and hMG 150IU

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011).
* Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:

* advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;
* a poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or
* an abnormal ovarian reserve test (antral follicle count, \<7 follicles or anti-Mullerian hormone, \<1.1 ng/ml).

Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No