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Efficacy and safety of progesterone injection II versus vaginal progesterone gel for luteal support in Chinese women undergoing hormone replacement frozen embryo transfer (HRT-FET): a prospective, open-label, non-inferiority, randomized controlled trial

Efficacy and safety of progesterone injection II versus vaginal progesterone gel for luteal support in Chinese women undergoing hormone replacement frozen embryo transfer (HRT-FET): a prospective, open-label, non-inferiority, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129138
Enrollment
Unknown
Registered
2026-07-31
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Infertility

Interventions

Investigational Group:Aqueous progesterone injection II, 25 mg, subcutaneous injection (SC), twice daily (bid)
combined with oral dydrogesterone, 10 mg, twice daily (bid).
Control Group:Progesterone vaginal gel 90 mg vaginally once daily, combined with dydrogesterone 20 mg orally twice daily.

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 42 Years

Inclusion criteria

Inclusion criteria: 1.Able to communicate well with researchers, understand and follow trial requirements, voluntarily participate, and understand and sign the informed consent form; 2.Women aged 20 to 42 years who are married when signing the ICF; 3.Body mass index (BMI) between 18 kg/m2 and less than 30 kg/m^2; 4.Using HRT-FET treatment, with endometrial thickness >=8mm after at least 10 days of estrogen use; 5.This cycle is the first frozen embryo transfer after egg retrieval, with at least 2-3 high-quality embryos or 1-2 blastocysts available for transfer.

Exclusion criteria

Exclusion criteria: 1. Recurrent miscarriage: Experiencing two or more consecutive losses of embryos or fetuses before 28 weeks of pregnancy, including consecutive biochemical pregnancies. 2. Repeated implantation failure: Defined as failing to achieve a clinical pregnancy after three or more embryo transfers, or after transferring 4-6 high-quality cleavage-stage embryos or 3 or more high-quality blastocysts (including fresh or frozen cycles). 3. Reproductive system diseases that affect pregnancy outcomes (any of the following): (1) Acute reproductive system infection; (2) Abnormal vaginal bleeding under investigation; (3) Severe uterine malformations or significant intrauterine lesions affecting embryo implantation (untreated); (4) Large uterine fibroids (diameter >4cm), etc.; 4. Allergy to active ingredients or excipients in progesterone drugs, or a history of related allergies, or clear contraindications to medication use; 5. Participation in other interventional clinical trials that may interfere; 6. Other situations where the researcher deems the participant unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy rate;

Secondary

MeasureTime frame
clinical pregnancy;

Countries

China

Contacts

Public ContactYang Rui

Peking University Third Hospital

roseli001@sina.com+86 10 8226 6699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026