Clinical trial NCT04531644: Double Stimulation in Women With Low Prognosis in ART
Official title: Impact of Double Stimulation (DuoStim) in Women Affected by Low Prognosis to Assisted Reproductive Technologies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Assisted Reproductive Techniques
Keywords: double ovarian stimulation
low prognosis women
ongoing pregnancy
Lead sponsor: Tu Du Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Federico II University
name: University of Medicine and Pharmacy at Ho Chi Minh City
First posted: 2020-08-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative Ongoing pregnancy rate
timeFrame: week 11 - 14 of pregnancy
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 2 weeks after embryo transfer
measure: Ongoing pregnancy rate
timeFrame: week 11 - 14 of pregnancy
measure: Number of oocytes retrieved
timeFrame: 4 hours after occyte pick-up
measure: Number of mature oocytes
timeFrame: 4 hours after oocyte pick-up
measure: Number of competent embryos
timeFrame: 3 days to 5 days after oocyte pick-up
measure: Fertilization rate
timeFrame: 1 to 3 days after oocyte pick-up
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Department of Infertility of Tu Du hospital
Study officials:
affiliation: Tu Du Hospital
name: Chau TM Le, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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. Epub 2014 Sep 6.
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 stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.
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 results in a similar euploid blastocyst formation rate: new insight in ovarian reserve exploitation. Fertil Steril. 2016 Jun;105(6):1488-1495.e1. doi: 10.1016/j.fertnstert.2016.03.002. Epub 2016 Mar 25.