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

Reproductive & Genetic Hospital of CITIC-Xiangya

Status: Unknown

Conditions: Infertility

Treatments: Drug: 150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation; Drug: 300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03914651

P2019002

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: Female

Ages: 35 to 42 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

300IU rFSH stimulation group

Active Comparator group

Description:

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.

Treatment:

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

150IU rFSH stimulation group

Experimental group

Description:

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

Treatment:

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