Clincosm LogoSign in Get a demo

Double Stimulation in Women With Low Prognosis in ART

Sponsor
Tu Du Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04531644
Collaborator
Federico II University (Other), University of Medicine and Pharmacy at Ho Chi Minh City (Other)
100
Enrollment
1
Location
2
Arms
30.6
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: double stimulation
  • Procedure: conventional ovarian stimulation
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Double Stimulation (DuoStim) in Women Affected by Low Prognosis to Assisted Reproductive Technologies
Actual Study Start Date :
May 14, 2020
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study

the patients in this group will be treated with double stimulation

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

    		•
    Active Comparator: Control

    the patients in this group will be treated with conventional ovarian stimulation

    Procedure: conventional ovarian stimulation
    the patients will be treated with one conventional ovarian stimulation in one cycle

    Outcome Measures

    Primary Outcome Measures

    1. Cumulative Ongoing pregnancy rate [week 11 - 14 of pregnancy]

      calculated by the number of ongoing pregnancy patients divided by the total number of patients in appropriate group

    Secondary Outcome Measures

    1. Pregnancy rate [2 weeks after embryo transfer]

      beta-hCG test is positive

    2. Ongoing pregnancy rate [week 11 - 14 of pregnancy]

      defined as the pregnancy completed 11 - 14 weeks of gestation and having vital fetus

    3. Number of oocytes retrieved [4 hours after occyte pick-up]

      Number of oocytes retrieved identified by the embryologists

    4. Number of mature oocytes [4 hours after oocyte pick-up]

      Number of mature oocytes identified by the embryologists

    5. Number of competent embryos [3 days to 5 days after oocyte pick-up]

      Number of embryos that can be transferred

    6. Fertilization rate [1 to 3 days after oocyte pick-up]

      number of fertilized oocyted divided by number of mature oocytes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Infertility of Tu Du hospital Ho Chi Minh City Vietnam 70000

    Sponsors and Collaborators

    • Tu Du Hospital
    • Federico II University
    • University of Medicine and Pharmacy at Ho Chi Minh City

    Investigators

    • Study Director: Chau TM Le, PhD, Tu Du Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Le Thi Minh Chau, Head of department of Infertility, Tu Du Hospital
    ClinicalTrials.gov Identifier:
    NCT04531644
    Other Study ID Numbers:
    • CS/TD/20/05
    First Posted:
    Aug 28, 2020
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Le Thi Minh Chau, Head of department of Infertility, Tu Du Hospital
    double ovarian stimulation
    low prognosis women
    ongoing pregnancy

    Study Results

    No Results Posted as of Sep 14, 2021