Comparative study of Letrozole vs Ganirelix acetate in ovarian hyperstimulation syndrome (OHSS)

Randamized prospective pilot study to compare use of aromatase inhibitor (Letrozole) versus gonadotrophin antagonist (Ganirelix acetate) for prevention of early-stage ovarian hyperstimulation syndrome (OHSS) in In-Vitro fertilization (IVF) Cycles

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028674

Enrollment

105

Registered

2020-10-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: N00-N99- Diseases of the genitourinary system

Interventions

Intervention1: Letrozole: aromatase inhibitor (Letrozole) for prevention of early-stage ovarian hyperstimulation syndrome (OHSS) occurrence. 2.5mg twice daily for 7 days , oral intake of drug Control

Eligibility

Inclusion criteria

Inclusion criteria: Body mass index is 18 to 29 USG pelvis normal with presence of both ovaries AFC > 20 (More than 20 follicles developing on folliculometry) AMH > 5 Basal levels of oestradiol ( Serum estradiol level > 4000 pg/ml on the day of trigger All patients had to sign an informed consent and Review Board permission was obtained Number of oocyte retrieval >25; Estradiol level > 3500 pg/mL on the day of trigger Clinical or ultrasonography proven OHSS on the day of oocyte retrieval, such as ultrasonographic evidence of ascites. Ovary diameter 10cm on one or both sides on day 3 after oocyte retrieval Puncture follicle number should be 30 (follicular diameter14mm on oocyte retrieval day)

Exclusion criteria

Exclusion criteria: 1.All women with serum estradiol levels 2.Not receiving dual trigger 3.Contraindications to study drugs

Design outcomes

Primary

Measure	Time frame
To investigate the effect of letrozole, an oral aromatase inhibitor, on serum E2 levels, when administered during the luteal phase after oocyte retrieval in IVF/ intracytoplasmic sperm injection (ICSI) cycles for prevention of Ovarian Hyperstimulation Syndrome (OHSS).Timepoint: Day 5 and Day 7	—

Secondary

Measure	Time frame
To investigate the effect of letrozole, an oral aromatase inhibitor, on serum E2 levels, when administered during the luteal phase after oocyte retrieval in IVF/ intracytoplasmic sperm injection (ICSI) cycles for prevention of Ovarian Hyperstimulation Syndrome (OHSS).Timepoint: day 5 and day 7	—

Countries

India

Contacts

Public ContactDr Kedar Ganla

Ankoor Fertility Clinic

drkedarganla@gmail.com9820450061

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026