CClinicalTrials.gg
Not yet recruitingNCT06093984Updated Oct 23, 2023

Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders

An interventional study of duostim vs. two antagonist ovarian stimulations in Infertility, sponsored by Shanghai First Maternity and Infant Hospital. Not yet recruiting. Open to female participants aged 20 Years to 44 Years. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by Shanghai First Maternity and Infant Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
20 Years to 44 Years
Sex
Female
01

Study summary

To compare the difference in cumulative live birth rates between dual ovarian stimulation and two antagonist stimulations in poor ovarian responders.

Read the detailed description

Studies have shown the ability to obtain oocytes with equivalent quality from the follicular and the luteal phase, and a higher number of oocytes within one cycle when using dual ovarian stimulation (duostim). This could be particularly relevant for women with poor ovarian responders (POR). Whether the cumulative live birth rates differ after duostim and two antagonist stimulations in POR remains controversial.

02

Conditions studied

  • Infertility

Browse trials for

03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 260 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Shanghai First Maternity and Infant Hospital is the lead sponsor of 45 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women with POR were defined with adjusted Bologna criteria, at least two of the three following criteria: advanced maternal age (40 years); 3 oocytes in previous IVF; and antral follicle count (AFC) 5 and/or anti-Mu¨llerian hormone (AMH) 1.1 ng/ml (this criterion was mandatory)
  • Aged from 20 to 44 years
  • Body mass index (BMI) from 19 to 32 kg/m2
  • No more than two previous IVF cycles were recruited

Exclusion criteria

Exclusion Criteria:

  • Amenorrhoea
  • Follicle stimulating hormone (FSH) 20 IU/L or AFC 1
  • Women with a partner with an extremely severe sperm anomaly or sperm donor use
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
260 participants (estimated)

Study arms

  • Experimental
    Dual Stimulation Protocol

    Dual stimulations were performed during the follicular and luteal phases in the same cycle.

    Procedure: duostim vs. two antagonist ovarian stimulations

  • Active comparator
    Antagonist Stimulation Protocol

    Antagonist stimulations were performed during two consecutive follicular phases in two cycles.

    Procedure: duostim vs. two antagonist ovarian stimulations

Interventions

  • Procedureduostim vs. two antagonist ovarian stimulations

    Human menopausal gonadotropin (HMG) 300 IU/day with flexible antagonist protocol is used for ovarian stimulation, except in luteal phase stimulation of the duostim group. In the duostim group, all of the embryos are frozen. Fresh transfers are performed in the control group, frozen embryo transfers are performed in both control and duostim groups.

06

What researchers measure

Primary outcomes

  1. Cumulative live birth rate

    Live birth is defined as the delivery of any alive infant after 22 weeks of gestation after our interventions, and cumulative live birth rate is calculated by the total number of women randomized to the specific group.

    Time frame: 36 months

Secondary outcomes

  1. Time to live birth (TTLB)

    The TTLB was measured as the time from ovarian stimulation to a live birth.

    Time frame: 36 months

  2. Total amount of Gn used during ovarian stimulation

    Total amount of Gn used during ovarian stimulation

    Time frame: 24 months

  3. Number of retrieved oocytes

    Number of retrieved oocytes after ovarian stimulation.

    Time frame: 24 months

  4. Clinical pregnancy rate

    Twenty days after conception, transvaginal ultrasonography will be performed. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.

    Time frame: 36 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06093984
Lead sponsor
Shanghai First Maternity and Infant Hospital
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Nov 1, 2023 (estimated)
Primary completion
Oct 30, 2025 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Oct 23, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion