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The Effect of Estrogen Supplementation on Clinical Pregnancy Rate in Letrozole-Induced Ovulation: A Prospective Randomized Controlled Trial

The Effect of Estrogen Supplementation on Clinical Pregnancy Rate in Letrozole-Induced Ovulation: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115444
Enrollment
Unknown
Registered
2025-12-26
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Polycystic Ovary Syndrome (PCOS) is characterized by:· Hyperandrogenism (clinical or biochemical)· Ovulatory dysfunction (e.g., oligo-ovulation or anovulation)· Polycystic ovarian morphology on ultrasound· It is frequently associated with insulin resistance, obesity, and metabolic syndrome.

Interventions

Letrozole-Only Group (i.e., LE + E(0mg) Group):Estrogen supplementation at 0 mg/day
Letrozole + Estrogen (4 mg/day) Group:Estrogen supplementation at 4 mg/day

Sponsors

Dongguan People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
22 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged 22-45 years, meeting the 2018 Chinese diagnostic criteria for Polycystic Ovary Syndrome (PCOS). 2. Diagnosed with ovulatory dysfunction infertility and scheduled for ovulation induction therapy. 3. Normal baseline sex hormone levels (FSH, LH, E2, PRL, T) and thyroid function. 4. Body Mass Index (BMI) >= 18 kg/m², with no severe medical comorbidities (e.g., diabetes, hypertension, history of thrombosis).

Exclusion criteria

Exclusion criteria: 1. Presence of severe comorbidities affecting the cardiovascular, cerebrovascular, hepatic, or renal systems, malignancies, or hematopoietic dysfunction. 2. Uterine abnormalities (e.g., polyps, adhesions, malformations), endometriosis, or hydrosalpinx. 3. Abnormal semen analysis in the male partner, as defined by WHO criteria. 4. Known allergy or hypersensitivity to any of the study medications. 5. Poor compliance, diagnosed psychiatric disorders (including those formally diagnosed by a psychiatrist or psychologist, such as severe anxiety or depression), or inability to communicate effectively. 6. Family history of thrombosis.

Design outcomes

Primary

MeasureTime frame
clinical pregnancy rate;

Secondary

MeasureTime frame
Endometrial thickness on the day of HCG administration;Ovulation Rate;Hormone levels (Estrogen, Progesterone, LH) on the day of hCG administration;

Countries

China

Contacts

Public ContactAihua Wu

Dongguan People's Hospital

737554434@qq.com+86 769 2863 7685

Outcome results

None listed

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