Reduced Oestrogen Dosage to Improve the Outcome of Frozen-thawed Embryo Transfer

NCT05545592 | Recruiting

• 1 other identifier: SZ-HRT-2022
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, randomized, controlled prospective study. Those who will recieve hormone replacement therapy-frozen thawed embryo transfer (HRT-FET) are enrolled in the study. To determine the effect of oestrogen dosage reducion on maternal and fetal complications in HRT-FET cycles while maintaining the similar clinical pregnancy outcome in HRT-FET cycles with regular oestrogen dosage.

Conditions

FET

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Clinical pregnancy is defined as the presence of gestational sac observed by ultrasound. The proportion of clinical pregnancy cycles to total FET cycles is the clinical pregnancy rate.

  45 days after embryo transfer

Secondary Outcomes (6)

• Embryo implantation rate

  45 days after embryo transfer

• Early pregnancy loss rate

  12 weeks after embryo transfer

• Incidence of thrombosis

  12 weeks after embryo transfer

• Incidence rate of gestational hypertension

  45 weeks after embryo transfer

• Premature birth rate

  41 weeks after embryo transfer

Study Arms (2)

Low oestrogen

EXPERIMENTAL

The patients take orally estradiol tablets 2 mg (Femoston) q.d. during the HRT-FET cycles

Other: Low oestrogen dosage

Regular oestrogen

NO INTERVENTION

The patients take orally estradiol tablets 2 mg (Femoston) t.i.d. during the HRT-FET cycles

Interventions

Low oestrogen dosage OTHER

From the second day of the menstrual cycle, femoston (estradiol tablets) were orally taken 2 mg q.d.. The endometrial thickness and serum oestrogen and progesterone levels were monitored on the 12th to 14th days of the menstrual cycle.

Low oestrogen

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female;
• Aged between 20 and 40 years old;
• Frozen thawed embryo transfer is proposed, and the type of transferred embryo is blastocyst (the number of transferred embryos is 1);
• Body mass index (BMI) ≤ 28 kg/m2, ≥ 18.5 kg/m2;
• The total number of transfer cycles was \< 3;
• Volunteer to participate in the study and sign the informed consent.

You may not qualify if:

• Patients with chromosomal abnormalities;
• Contraindications to hormone replacement therapy;
• Patients with uterine myoma, severe adenomyosis, endometriosis, congenital uterine malformation, endometrial tuberculosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
• Participating in other clinical studies.

Sponsors & Collaborators

• Nanjing University: lead

Study Sites (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Central Study Contacts

Jun Xing

CONTACT

+862583107188; xing.jun@msn.com

Chenyang Huang

CONTACT

+862583107188; dianshui19901562@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 19, 2022
• Study Start: October 1, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

CN (1)