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

Not Applicable

• Conditions: Infertility
• Interventions: Drug: 300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation; Drug: 150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation

• Registration Number: NCT03914651
• Lead Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-16
• Study Start: 2019-04-23
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-12
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
300IU rFSH stimulation group	300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation	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.
150IU rFSH stimulation group	150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation	150IU rFSH Gonal-F® stimulation group is defined as patients using GnRH antagonist protocol with a 150IU rFSH starting dose during controlled ovarian stimulation.

Primary Outcome Measures

Name	Time	Method
Cumulative live birth rate	22 months	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.

Secondary Outcome Measures

Name	Time	Method
Neonatal malformation rate	22 months	Number of infant diagnosed as neonatal malformation / the total number of infant delivered after 28 weeks of gestation.
Multiple pregnancy rate	22 months	Number of multiple pregnancies / number of clinical pregnancies over (up to) 3 transfers within 1 year.
Time to live birth	22 months	Time to live birth is defined as the interval between the date of randomization and achieving live birth.
Cycle cancellation rate	1 month	Cycle cancellation is defined as cycle cancelled before obtaining at least one viable embryo for any reason. And cycle cancellation rate is calculated by dividing the number of women cancelled their cycle before obtaining at least one viable embryo for any reason by the total number of women randomized to the specific group.
Number of MII eggs	1 month	MII eggs is defined as eggs retrieved that reach the MII phase.
Cumulative Clinic pregnancy rate	14 months	Clinic pregnancy will be diagnosed with the detection of an intrauterine gestation sac. And cumulative clinic pregnancy rate is calculated by the number of women who achieves clinical pregnancy after transfers of all study-specific embryos (within 1 year after randomization) by the total number of women randomized to the specific group.
cumulative pregnancy loss rate	19 months	Pregnancy loss is defined as a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation. And cumulative pregnancy loss rate is calculated as the number of pregnancy losses / number of clinical pregnancy after transfers of all study-specific embryos (within 1 year after randomization).
Implantation rate	14 months	Number of gestation sac detected / number of embryo transferred.
Good quality embryo rate	1 month	Good quality embryo is defined as embryo that is graded as 6CII or better or blastocyst. And good quality embryo rate is calculated by dividing the number of good quality embryo by the total number of embryo obtained after fertilization in the specific group.
Birth weight	22 months	Weight of newborns at delivery

Trial Locations

Locations (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA; 🇨🇳 Changsha, Hunan, China