Double Stimulation in Women With Low Prognosis in ART
Impact of Double Stimulation (DuoStim) in Women Affected by Low Prognosis to Assisted Reproductive Technologies
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2020
CompletedFirst Submitted
Initial submission to the registry
August 18, 2020
CompletedFirst Posted
Study publicly available on registry
August 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedDecember 6, 2023
December 1, 2023
3.8 years
August 18, 2020
December 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Pregnancy rate
2 weeks after embryo transfer
Ongoing pregnancy rate
week 11 - 14 of pregnancy
Number of oocytes retrieved
4 hours after occyte pick-up
Number of mature oocytes
4 hours after oocyte pick-up
Number of competent embryos
3 days to 5 days after oocyte pick-up
- +1 more secondary outcomes
Study Arms (2)
Study
EXPERIMENTALthe patients in this group will be treated with double stimulation
Control
ACTIVE COMPARATORthe patients in this group will be treated with conventional ovarian stimulation
Interventions
the patients will be treated with two consecutive ovarian stimulations in one cycle
the patients will be treated with one conventional ovarian stimulation in one cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tu Du Hospitallead
- Federico II Universitycollaborator
- University of Medicine and Pharmacy at Ho Chi Minh Citycollaborator
Study Sites (1)
Department of Infertility of Tu Du hospital
Ho Chi Minh City, 70000, Vietnam
Related 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.
PMID: 28837031RESULTKuang 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.
PMID: 25444501RESULTPoseidon 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.
PMID: 26921622RESULTUbaldi 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.
PMID: 27020168RESULT
Study Officials
- STUDY DIRECTOR
Chau TM Le, PhD
Tu Du Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of department of Infertility
Study Record Dates
First Submitted
August 18, 2020
First Posted
August 28, 2020
Study Start
May 14, 2020
Primary Completion
February 28, 2024
Study Completion
March 30, 2024
Last Updated
December 6, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share