CLBR Per Initial Cycle With Different Starting Dose in Aged Patients With Poor Ovarian Reservation: 300IU Versus 150IU

NCT ID: NCT03914651

Last Updated: 2022-01-12

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-23

Study Completion Date

2022-12-30

Brief Summary

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

Among aged patients with poor ovarian reservation(defined as age 35 to 42 years; antral follicle count(AFC)≤ 5 or anti-mullerian hormone(AMH)≤ 1.2 ng/ml), cumulative live birth rate(CLBR) and time to live birth(TTLB) of the first stimulation cycle were compared between a starting dose of 300IU or 150IU rFSH in controlled ovarian stimulation with gonadotropin-releasing hormone(GnRH)antagonist protocol. This study is a prospective randomized controlled trial.

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.

300IU rFSH stimulation group

300IU rFSH stimulation group is defined as patients using gonadotropin-releasing hormone(GnRH)antagonist protocol with a 300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation.

Group Type ACTIVE_COMPARATOR

300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation

Intervention Type DRUG

On menstrual cycle day 2 or day 3, 300IU rFSH Gonal-F® will be administrated daily till the day of trigger. The dosage of rFSH can be adjusted only if there is a risk of ovarian hyperstimulation syndrome(OHSS).

150IU rFSH stimulation group

150IU rFSH Gonal-F® stimulation group is defined as patients using GnRH antagonist protocol with a 150IU rFSH starting dose during controlled ovarian stimulation.

Group Type EXPERIMENTAL

150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation

Intervention Type DRUG

On menstrual cycle day 2 or day 3, 150IU rFSH Gonal-F® will be administrated daily till the day of trigger. The dosage of rFSH can be adjusted only if there is a risk of OHSS or insufficient follicular growth.

Interventions

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

300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation

On menstrual cycle day 2 or day 3, 300IU rFSH Gonal-F® will be administrated daily till the day of trigger. The dosage of rFSH can be adjusted only if there is a risk of ovarian hyperstimulation syndrome(OHSS).

Intervention Type DRUG

150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation

On menstrual cycle day 2 or day 3, 150IU rFSH Gonal-F® will be administrated daily till the day of trigger. The dosage of rFSH can be adjusted only if there is a risk of OHSS or insufficient follicular growth.

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

1. Age Limits≥35 and≤42;
2. AFC≤5 or AMH≤1.2ng/ml;
3. BMI≤30kg/m2;
4. The first IVF/intracytoplasmic sperm injection (ICSI) cycle;

Exclusion Criteria

1. Any other underlying disease or condition considered IVF is contraindicated.
2. Ovarian hyperstimulation syndrome(PCOS), moderate or severe intrauterine adhesion,untreated hydrosalpinx, adenomyosis, any myoma in cases that endometrium was affected, intramural larger than 4cm.
3. Autoimmune antibody positive, untreated.
4. History of recurrent miscarriages.
5. Patients seeking for Preimplantation Genetic Testing(PGT) treatment.
6. Simultaneous participation in another clinical study.
7. According to the judgment of the investigator, any reason or condition that precludes subject for participating in the study.
Minimum Eligible Age

35 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Reproductive & Genetic Hospital of CITIC-Xiangya

OTHER

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xiaofeng Li, doctor

Role: primary

0731-82355100

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P2019002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.