NCT03914651

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

April 23, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 12, 2022

Status Verified

January 1, 2022

Enrollment Period

3.7 years

First QC Date

April 11, 2019

Last Update Submit

January 10, 2022

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Cumulative live birth rate

    Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions。And cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (within 1 year after randomization) by the total number of women randomized to the specific group.

    22 months

Secondary Outcomes (10)

  • Time to live birth

    22 months

  • Cycle cancellation rate

    1 month

  • Number of MII eggs

    1 month

  • Cumulative Clinic pregnancy rate

    14 months

  • cumulative pregnancy loss rate

    19 months

  • +5 more secondary outcomes

Study Arms (2)

300IU rFSH stimulation group

ACTIVE COMPARATOR

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.

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

150IU rFSH stimulation group

EXPERIMENTAL

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

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

Interventions

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

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）.

300IU rFSH stimulation group
150IU rFSH Gonal-F® starting dose during controlled ovarian stimulationDRUG

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.

150IU rFSH stimulation group

Eligibility Criteria

Age35 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

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

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 16, 2019

Study Start

April 23, 2019

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

January 12, 2022

Record last verified: 2022-01

Locations

CN(1)