A RCT Comparing Spontaneous Natural Cycles and Human Chorionic Gonadotrophin-induced Natural Cycles in FET

NCT02197208 | Completed

• 1 other identifier: HKU-VL-NChCGFET
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a randomized controlled trial on the comparison of the ongoing pregnancy rate in frozen-thawed embryo transfer cycles with spontaneous ovulation and hCG-induced natural cycles.

Conditions

Subfertility; Pregnancy

Keywords

Frozen-thawed embryo transfer; natural cycle; spontaneous ovulation; hCG induced natural cycles

Outcome Measures

Primary Outcomes (1)

• ongoing pregnancy rate

  the ongoing pregnancy rate which is defined as the number of viable pregnancies beyond 10-12 weeks gestation per transfer cycle

  12 weeks after embryos transfer

Secondary Outcomes (7)

• Days of monitoring for timing FET

  4 weeks after last menstrual period

• Endometrial thickness on day of hCG or the next day after LH surge

  2-3 weeks after LMP

• Implantation rate

  4-6 weeks after embryo transfer

• pregnancy rate

  2-4 weeks after embryo transfer

• Clinical pregnancy rate

  6-8 weeks after embryo transfer

Study Arms (2)

Spontaneous NC

ACTIVE COMPARATOR

Timing by the onset of LH surge as shown daily blood monitoring of serum estradiol and LH levels

Procedure: Daily monitoring of LH and E2; Device: ultrasound

hCG induced NC

EXPERIMENTAL

Timing by giving hCG when the dominant follicle reaches \>=17mm in diameter on ultrasound monitoring

Procedure: hCG induced natural cycle; Device: ultrasound

Interventions

Daily monitoring of LH and E2 PROCEDURE

ultrasound scanning would be carried out from 18 days before the expected period to confirm follicular growth, followed by daily blood monitoring of serum E2 and LH levels when the dominant follicle reaches 13-14mm in diameter. Ultrasound scanning can be arranged accordingly if the leading follicle remains less than 10mm in diameter. 5 ml of blood would be taken daily. LH surge is defined as the LH level being double of the average of the previous three days and higher than 20 IU/L. Ultrasound examination will be performed on the next day after the LH surge to measure the endometrial thickness. The transfer will be scheduled three or four days after the LH surge (for cleavage stage embryos) or six days after LH surge (for blastocyst transfer).

Spontaneous NC

hCG induced natural cycle PROCEDURE

ultrasound monitoring would be started from 18 days before the expected period to monitor follicular growth, followed by USG every 2-3 days. hCG, 5,000-10,000 IU will be given when the leading follicle is \>/= 17 mm and the endometrium measures \>/=8 mm. Serum E2, LH and progesterone levels will be measured on the day of hCG. Embryo transfer would be scheduled on the fourth or fifth days after hCG injection (for cleavage stage embryos) or seventh days (for blastocyst transfer).

hCG induced NC

ultrasound DEVICE

Spontaneous NC; hCG induced NC

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age of women \<43 years
• Regular menstrual cycles ranging from 21-35 days with not more than 4 days variation between cycles
• Undergoing FET in natural cycles
• Normal uterine cavity as shown on saline sonogram performed before the IVF cycle or normal uterine cavity shown on pelvic scanning during the stimulated IVF cycle
• Endometrial thickness \>=8mm in both stimulated IVF and FET cycles

You may not qualify if:

• \>3 previous IVF cycles
• \>6 embryos replaced without pregnancy
• Irregular menstrual cycles
• Subjects requiring clomid-induced cycles and hormonal replacement (HRT) cycles
• History of previous FET cycles within the study period
• Blastocyst transfer
• Preimplantation genetic diagnosis treatment
• Use of donor oocytes
• Presence of hydrosalpinx not corrected surgically prior to FET
• Recurrent miscarriage
• Serum progesterone level on the day of LH surge or day of hCG \>5 nmol/L or 1.5 pg/L (these patients will be retrospectively excluded)
• Refusal to join the study

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University

Guangzhou, China

Location

Queen Mary Hospital

Hong Kong, Hong Kong, 852, Hong Kong

Location

MeSH Terms

Conditions

Infertility

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Vivian CY Lee, MBBS

  Queen Mary Hospital / University of Hong Kong.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2014
• First Posted: July 22, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

CN (1); HK (1)