Suspended

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

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What is being tested

double stimulation

+ conventional ovarian stimulation

Procedure
Who is being recruted

From 18 to 40 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2020
See protocol details

Summary

Principal SponsorTu Du Hospital
Study ContactChau TM Le, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 14, 2020

Actual date on which the first participant was enrolled.

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.

Official TitleImpact of Double Stimulation (DuoStim) in Women Affected by Low Prognosis to Assisted Reproductive Technologies
NCT04531644
Principal SponsorTu Du Hospital
Study ContactChau TM Le, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Age ≤ 40.
AMH ≥ 0.3 ng/ml and ≤ 1.2 ng/ml.
OR 3 ≤ AFC ≤7.
Normal shape of uterus (based on ultrasound).
Show More Criteria
9 exclusion criteria prevent from participating
Asherman's syndrome.
Endometriosis.
Leiomyomas distorting the endometrium
Sperm extracted from surgical procedures (i.e. PESA, TESE).
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
the patients in this group will be treated with double stimulation

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Infertility of Tu Du hospital

Ho Chi Minh City, VietnamOpen Department of Infertility of Tu Du hospital in Google Maps
SuspendedOne Study Center