Modified Downregulation for Women With Adenomyosis of the Uterus Prior to Frozen-thawed Embryo Transfer.

• Status: Recruiting
• Trial end date: 2024-05-17
• Target enrollment: 0
• Participant gender: Female

Summary

1 in 7 couples experience difficulty in conceiving. Many will require in vitro fertilization (IVF). IVF involves an initial period of downregulation to suppress the ovaries and prevent premature ovulation. Hormone injections are then used to stimulate a woman's ovaries to produce eggs which are removed by a minor operation. The harvested eggs are mixed with sperm to create embryos in the laboratory. These embryos are replaced in the womb a few days after they are created (fresh embryo transfer). Any remaining embryos are frozen such that they can be thawed and transferred at a later date (frozen thawed embryo transfer, FTET).

The investigators have previously shown that the presence of moderate or severe adenomyosis significantly reduces the chance of clinical pregnancy after embryo transfer. The purpose of this study is to examine whether it is possible to improve the chance of clinical pregnancy in these women by modifying the IVF protocol they undergo for FTET.

The hypothesis is that a prolonged downregulation regimen for women with adenomyosis would reduce the inflammatory reaction in the endometrium of these women and thus improve the chance of implantation after embryo transfer.

Consenting patients will be offered FTET. Those proceeding will be randomized to one of two protocols (A - standard protocol vs. B - prolonged downregulation protocol). Women will also be offered a questionnaire before and after IVF treatment to assess their adenomyosis symptoms .

The primary outcome of the study is clinical pregnancy defined as an intrauterine pregnancy with a visible heart beat older than 6 weeks gestation. Secondary outcomes include livebirth, pregnancy loss (biochemical pregnancy, miscarriage, ectopic pregnancy, stillbirth, termination of pregnancy), gestational age at delivery, birth weight, neonatal mortality, major congenital anomaly, serious medication reaction, number of frozen embryos available for transfer, number of days to achieve optimal endometrial thickness.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London

Criteria

Inclusion Criteria:

1. Couples who are undergoing a cycle of IVF/ICSI, where a cycle is defined as egg collection following ovarian stimulation.

2. The female partner is ≥18 and < 42 years of age.

3. The female partner has a BMI <30.

4. Two out of three of the following criteria are met: AMH >5.4, FSH <8.9, antral follicle count >4.

5. Moderate or severe adenomyosis of the uterus diagnosed on ultrasound scan.

6. Both partners are willing and able to provide written informed consent.

Exclusion Criteria:

1. Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within the previous 3 months of study enrolment.

2. Previous open or laparoscopic myomectomy

3. Uterine fibroids (untreated FIGO Type 0-I-II and type III-IV fibroids > 3 cm)

4. Use of GnRH analogues within previous 3 months.

5. Severe male factor infertility (sperm count < 2 x 106/ml, use of surgically retrieved spermatozoa)

6. Couples who in the opinion of the researcher by virtue of language or learning impairment would be unable to give fully informed consent to the study.