Table 1

WHO trial registration data

Data categoryInformation
Primary registry and trial identifying numberClinicalTrials.gov
NCT03946722
Date of registration in primary registry13 May 2019
Source of monetary or material supportDimitrios Mavrelos (CI)
Primary sponsorUniversity College London
Contact for public queriesDM, SL (dimitrios.mavrelos@nhs.net, sanialatif@nhs.net)
University College London Hospital, UK
Contact for scientific queriesDM, SL (dimitrios.mavrelos@nhs.net, sanialatif@nhs.net)
University College London Hospital, UK
Scientific titleModified downregulation for women with moderate/severe adenomyosis of the uterus prior to frozen-thawed embryo transfer.
Descriptive titleThe effectiveness of modified downregulation for women with moderate and severe adenomyosis of the uterus prior to frozen-thawed embryo transfer (MODA) study protocol: a pragmatic randomised controlled trial.
Public titleMODA
Countries of recruitmentUK
Health condition or problem studiedAdenomyosis
Intervention(s)Active comparator: prolonged downregulation for 6 weeks.
Placebo comparator: standard downregulation for 1 week.
Key inclusion and exclusion criteriaAges eligible for study: ≥18 years to <42 years
Sexes eligible for study: female
Accepts healthy volunteers: no
Inclusion criteria: women with moderate/severe adenomyosis undergoing IVF treatment, body mass index <30 kg/m2, two out of three of the following criteria are met: AMH >5.4 pmol/L, FSH <8.9 IU/L, antral follicle count >4.
Exclusion criteria: previous open or laparoscopic myomectomy, uterine fibroids (untreated FIGO type 0-I-II and type III-IV fibroids >3 cm), untreated endometrial polyps, untreated hydrosalpinges, use of GnRH analogues within previous 3 months, severe male factor infertility (sperm count <2×106/mL, use of surgically retrieved spermatozoa).
Study typeInterventional
Allocation: randomised intervention model.
Parallel assignment masking: unblinded.
Primary purpose: to determine effectiveness of modified downregulation.
Phase III
Date of first enrolmentOctober 2020
Target sample size162
Recruitment statusRecruiting
Primary outcomeClinical pregnancy rate
Key secondary outcomesLive birth, 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, frequency and severity of medication side effects, number of days to achieve optimal endometrial thickness.
  • AMH, anti-müllerian hormone; BMI, body mass index; CI, chief investigator; FIGO, The International Federation of Gynecology and Obstetrics; FSH, follicle stimulating hormone; GnRH, gonadotrophin-releasing hormone ; ICSI, intracytoplasmic sperm injection; IVF, in vitro fertilisation .