Modified Downregulation for Women With Adenomyosis of the Uterus Prior to Frozen-thawed Embryo Transfer. (MODA)
Adenomyosis
About this trial
This is an interventional treatment trial for Adenomyosis focused on measuring In vitro fertilisation, Assisted conception, Randomised controlled trial, Down-regulation
Eligibility Criteria
Inclusion Criteria:
- Couples who are undergoing a cycle of IVF/ICSI, where a cycle is defined as egg collection following ovarian stimulation.
- The female partner is ≥18 and < 42 years of age.
- The female partner has a BMI <30.
- Two out of three of the following criteria are met: AMH >5.4, FSH <8.9, antral follicle count >4.
- Moderate or severe adenomyosis of the uterus diagnosed on ultrasound scan.
- Both partners are willing and able to provide written informed consent.
Exclusion Criteria:
- Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within the previous 3 months of study enrolment.
- Previous open or laparoscopic myomectomy
- Uterine fibroids (untreated FIGO Type 0-I-II and type III-IV fibroids > 3 cm)
- Use of GnRH analogues within previous 3 months.
- Severe male factor infertility (sperm count < 2 x 106/ml, use of surgically retrieved spermatozoa)
- 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.
Sites / Locations
- University College London HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Experimental
Standard downregulation with GnRH analogue
Prolonged downregulation with GnRH analogue
Participants in this arm will be assigned to the routine IVF protocol currently being used in the investigators' IVF unit, as outlined below, with one week of downregulation. Downregulation is the suppression of the ovaries during an IVF cycle in order to perform controlled ovarian stimulation and prevent premature ovulation. Start progesterone (Norethisterone 5mg twice daily orally) on day 14 of downregulation cycle and continue for 11 days. Start GnRH analogue (Buserelin 0.5ml subcutaneously once daily) on day 21 of downregulation cycle and reduce to 0.2ml on day 1 of bleed. Baseline scan on day 1 - 5 of bleed and start oestrogen (Progynova 2mg three times daily orally). Serial scanning from day 10 until endometrial thickness more than 8mm. Once endometrial thickness more than 8mm start progesterone (Cyclogest 400mg twice daily vaginally/rectally and Lubion 25mg twice daily subcutaneously) and proceed to embryo transfer on appropriate day for embryo age.
Participants in this arm will be exposed to an additional five weeks of downregulation using a GnRH analogue. Downregulation is the suppression of the ovaries during an IVF cycle in order to perform controlled ovarian stimulation and prevent premature ovulation. Baseline scan on day 1-5 of bleed and administer GnRH analogue (Leuprorelin acetate 3.75 mg subcutaneously single injection). 28 days later administer second dose of GnRH analogue (Leuprorelin acetate 1.875 mg subcutaneously), and 21 days later start oestrogen (Progynova 2 mg three times daily orally). Serial scanning from day 10 of oestrogen until endometrial thickness more than 8mm. Once endometrial thickness more than 8mm start progesterone (Cyclogest 400mg twice daily vaginally/rectally and Lubion 25mg twice daily subcutaneously) and proceed to embryo transfer on appropriate day for embryo age.