Cumulative Live Birth After Double Stimulation Protocol Versus Antagonist Protocol for Poor Ovarian Responders

Cumulative Live Birth Rates in the Same Cycle Double Stimulation Protocol Versus a Two-cycle Antagonist Stimulation Protocol in IVF Patients With a Poor Prognosis: a Randomized Clinical Trial

To compare the difference in cumulative live birth rates within one year between double stimulations protocol and two-cycle antagonist protocol in poor ovarian responders.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility
• Intervention / Treatment: Procedure: Double Stimulation Protocol; Procedure: Antagonist Stimulation Protocol

Detailed Description

The theory of multicyclic development of follicles during the menstrual cycle prompted new approaches to ovarian stimulation such as double stimulation within the same menstrual cycle, in both follicular and luteal phases. The double ovarian stimulation protocol has been proposed to optimize the number of oocytes retrieved within the shortest possible timeframe.In general, the aim of DUOSTIM is to obtain the highest number of oocytes in the shortest time, thus avoiding waste of time, which is crucial for these patients.

• Study Type: Interventional
• Enrollment (Anticipated): 1198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women diagnosed with Poseidon criteria or expected poor ovarian responder （the number of oocyte retrieval ≤9）
2. Women aged ≥20 years old
3. Women who are undergoing their first or second ART cycles
4. Women who are undergoing IVF,ICSI or PGT-A cycles
5. Women with the number of oocyte retrieval ≤9 after their first ovarian stimulation cycle since radomization, and the number of follicle measuring 8mm or larger ≥3

Exclusion Criteria:

1. Women with RIF or RSA
2. Women diagnosed with uterine abnormalities including uterine malformations, adenomyosis, submucosal fibroids, uterine adhesions or endometrial polyps
3. Women with untreated hydrosalpinx that is visible under pelvic ultrasound
4. Women with chromosomal abnormalities, or women who are undergoning PGT-SR or PGT-M cycles
5. Women with a history of canceled FET cycle(s) due to a thin endometrium (<7mm)
6. Man with operation to get sperm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double Stimulation Protocol; Double stimulations were performed during the follicular and luteal phases in the same cycle by rFSH&hmg.	Procedure: Double Stimulation Protocol; cummulative live birth outcome after two cycles of in virto fertilization using double stimulation protocol, which refers to two cycles of ovarian stimulation in both follicular phase and luteal phase within the same menstrual cycle
Active Comparator: Antagonist Stimulation Protocol; The classical antagonist protocol were performed by rFSH,hmg and antagonist.	Procedure: Antagonist Stimulation Protocol; cummulative live birth outcome within no more than two cycles of in virto fertilization using classical antagonist protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (up to 3 transfers of single blastocycst within 1 year after randomization), by the total number of women randomized to the specific group.	36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of retrieved oocytes	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.	36 months
Incidence of obstetric complications	Number of pregnancies with complications / number of pregnancies.	36 months
Incidence of perinatal complications	Number of live births with neonatal complications / number of live births.	36 months
Cost-effectiveness analysis	Cost-effectiveness will be evaluated by comparing the two groups in terms of costs and benefits	36 months
Birth weight	Weight of newborns at delivery	36 months
Total amount of Gn used during ovarian stimulation		24 months

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: The Affiliated Hospital of Qingdao University; Reproductive & Genetic Hospital of CITIC-Xiangya; The Affiliated Hospital of Inner Mongolia Medical University; Guangdong Second Provincial General Hospital; Hunan Provincial Maternal and Child Health Care Hospital; Xinjiang Jiayin Hospital; Jinghua Hospital of Shenyang; Wuhan Tongji Reproductive Medicine Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 14, 2023
• Primary Completion (Anticipated): March 1, 2026
• Study Completion (Anticipated): April 1, 2026

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Poseidon criteria; Double stimulation; Cummulative live birth
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: DouAnt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No