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

NCT03914651 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2022-01-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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）.

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.

Sponsors & Collaborators

  • Reproductive & Genetic Hospital of CITIC-Xiangya

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-23
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03914651 on ClinicalTrials.gov