Double Stimulation in Women With Low Prognosis in ART

Assisted Reproductive Techniques Clinical Trial

Official title:

Impact of Double Stimulation (DuoStim) in Women Affected by Low Prognosis to Assisted Reproductive Technologies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04531644
• Other study ID #: CS/TD/20/05
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2020
• Est. completion date: March 30, 2024

Study information

• Verified date: December 2023
• Source: Tu Du Hospital
• Contact: Chau TM Le, PhD
• Phone: +84908429006
• Email: dr.lethiminhchau[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to compare the cumulative ongoing pregnancy rates of two different IVF protocols in women candidate for ART characterized by low prognosis.

Description:

The patients will be allocated into two groups: control and study group _ In study group, patients will be treated by DuoStim protocol: The first phase of ovarian stimulation is started on the second day or third day of period. GnRH agonist will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. Five days later after oocyte retrieval, the second stimulation will be started. All embryos will be cryopreserved.

_ In control group, patients will be treated with antagonist protocol: The cycle of ovarian stimulation is started on the second day or third day of period. hCG will be used to trigger when at least two follicles ≥ 17 mm. Approximately 36 hours later, oocytes will be retrieved vaginally under ultrasound monitoring and ICSI will be performed. If serum progesterone on the day of trigger ≥ 1.5 ng/ml, all embryos will be cryostored; otherwise, fresh embryos will be transferred.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age = 40.

• AMH = 0.3 ng/ml and = 1.2 ng/ml.

• OR 3 = AFC =7.

• Normal shape of uterus (based on ultrasound).

• Body mass index within 28 - 37 kg/m2

Exclusion Criteria:

• Asherman's syndrome.

• Endometriosis.

• Leiomyomas distorting the endometrium

• Sperm extracted from surgical procedures (i.e. PESA, TESE).

• Patients refuse to continue participating in the study.

• Patients injected with wrong dose of gonadotropins during the treatment.

• Serious complications or accidents arise forcing the patients to discontinue the treatments.

• Ovarian surgery

• Previous chemotherapy or pelvic irradiation

Related Conditions & MeSH terms

• Assisted Reproductive Techniques

Intervention

Procedure:
• double stimulation
the patients will be treated with two consecutive ovarian stimulations in one cycle
• conventional ovarian stimulation
the patients will be treated with one conventional ovarian stimulation in one cycle

Locations

Country	Name	City	State
Vietnam	Department of Infertility of Tu Du hospital	Ho Chi Minh City

Sponsors (3)

Lead Sponsor	Collaborator
Tu Du Hospital	Federico II University, University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

References & Publications (4)

Cardoso MCA, Evangelista A, Sartorio C, Vaz G, Werneck CLV, Guimaraes FM, Sa PG, Erthal MC. Can ovarian double-stimulation in the same menstrual cycle improve IVF outcomes? JBRA Assist Reprod. 2017 Sep 1;21(3):217-221. doi: 10.5935/1518-0557.20170042. — View Citation

Kuang Y, Chen Q, Hong Q, Lyu Q, Ai A, Fu Y, Shoham Z. Double stimulations during the follicular and luteal phases of poor responders in IVF/ICSI programmes (Shanghai protocol). Reprod Biomed Online. 2014 Dec;29(6):684-91. doi: 10.1016/j.rbmo.2014.08.009. — View Citation

Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number); Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stra — View Citation

Ubaldi FM, Capalbo A, Vaiarelli A, Cimadomo D, Colamaria S, Alviggi C, Trabucco E, Venturella R, Vajta G, Rienzi L. Follicular versus luteal phase ovarian stimulation during the same menstrual cycle (DuoStim) in a reduced ovarian reserve population result — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Ongoing pregnancy rate	calculated by the number of ongoing pregnancy patients divided by the total number of patients in appropriate group	week 11 - 14 of pregnancy
Secondary	Pregnancy rate	beta-hCG test is positive	2 weeks after embryo transfer
Secondary	Ongoing pregnancy rate	defined as the pregnancy completed 11 - 14 weeks of gestation and having vital fetus	week 11 - 14 of pregnancy
Secondary	Number of oocytes retrieved	Number of oocytes retrieved identified by the embryologists	4 hours after occyte pick-up
Secondary	Number of mature oocytes	Number of mature oocytes identified by the embryologists	4 hours after oocyte pick-up
Secondary	Number of competent embryos	Number of embryos that can be transferred	3 days to 5 days after oocyte pick-up
Secondary	Fertilization rate	number of fertilized oocyted divided by number of mature oocytes	1 to 3 days after oocyte pick-up