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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05765968
• Other study ID #: DouAnt
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: March 2023
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1198
• Est. completion date: April 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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
• Antagonist Stimulation Protocol
cummulative live birth outcome within no more than two cycles of in virto fertilization using classical antagonist protocol

Locations

Country	Name	City	State
China	Shandong University	Jinan	Shandong

Sponsors (9)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Incidence of obstetric complications	Number of pregnancies with complications / number of pregnancies.	36 months
Other	Incidence of perinatal complications	Number of live births with neonatal complications / number of live births.	36 months
Other	Cost-effectiveness analysis	Cost-effectiveness will be evaluated by comparing the two groups in terms of costs and benefits	36 months
Other	Birth weight	Weight of newborns at delivery	36 months
Other	Total amount of Gn used during ovarian stimulation		24 months
Primary	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	Number of retrieved oocytes		24 months