To compares results of two IVF methods where each woman undergoes two egg retrievals one method starts ovarian stimulation in first half of the menstrual cycle (follicular phase) followed by the second half (luteal phase), while the other starts in the second half first and then the first half.

Comparison of luteal first dual stimulation (Luteal DUO-STIM) protocol with conventional follicular first dual stimulation (DUO-STIM) protocol in women undergoing IVF/ICSI cycles: A pilot randomised controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097844

Enrollment

Registered

2025-11-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N978- Female infertility of other origin

Interventions

Intervention1: Luteal DUOSTIM: In the Luteal DUOSTIM protocol, ovarian stimulation will be started from day 21 of preceeding cycle with injection human menopausal gonadotrophin, dose will be individua

Eligibility

Inclusion criteria

Inclusion criteria: 1. Infertile women less than 40 years of age undergoing IVF/ICSI cycle 2. AMH less than or equal to 3 ng/ml 3. Willing to participate in the study

Exclusion criteria

Exclusion criteria: 1. Grade 3 or higher endometriosis 2. Uterine anomalies, fibroid or adenomyoma distorting the endometrial cavity 3. Uncontrolled thyroid and/or prolactin disorders 4. Donor Recipient IVF cycles 5. Severe male factor infertility (requiring surgical sperm retrieval or severe OATS) 6. BMI less than 19 kg/m2 or greater than 35 kg/m2 7. Unwilling to participate in the study

Design outcomes

Primary

Measure	Time frame
Total oocyte yieldTimepoint: 1.5 to 2 years	—

Secondary

Measure	Time frame
1. Total dose of gonadotropins required 2. Duration of controlled ovarian stimulation of individual Luteal Phase Stimulation (LPS) and Follicular Phase Stimulation (FPS) as well as of complete Luteal DUO-STIM and conventional DUO-STIM 3. FORT (Follicular Output Rate) 4. FOI (Follicle to Oocyte Index) 5. Fertilization rate 6. Cleavage rate 7. Number of good quality embryos 8. Clinical pregnancy rate Timepoint: 1.5 to 2 years	—

Measure

Time frame

1. Total dose of gonadotropins required 2. Duration of controlled ovarian stimulation of individual Luteal Phase Stimulation (LPS) and Follicular Phase Stimulation (FPS) as well as of complete Luteal DUO-STIM and conventional DUO-STIM 3. FORT (Follicular Output Rate) 4. FOI (Follicle to Oocyte Index) 5. Fertilization rate 6. Cleavage rate 7. Number of good quality embryos 8. Clinical pregnancy rate Timepoint: 1.5 to 2 years

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Countries

India

Contacts

Public ContactProf Reeta Mahey

All India Institute of Medical Sciences

rakshasoni12@gmail.com8860765646

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026