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MODA
Sponsor study identifier
interventional
162
1 country
1
Study Start
August 17, 2020
Actual (reported)Primary Completion
August 17, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 17, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 17, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 7, 2019
Actual (reported)May 13, 2019
Actual (reported)August 17, 2020
Actual (reported)August 17, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 17, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Clinical pregnancy rate
Clinical pregnancy is defined as an intrauterine pregnancy with a visible heart beat older than 6 weeks gestation.
6 weeks after embryo transfer
Livebirth
9 months after embryo transfer
Pregnancy loss
9 months after embryo transfer
Gestational age at delivery
9 months after embryo transfer
Birthweight at delivery
9 months after embryo transfer
Neonatal mortality
9 months after embryo transfer
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.
Downregulation is the suppression of the ovaries during an IVF cycle in order to perform controlled ovarian stimulation and prevent premature ovulation. Participants will be exposed to one week of downregulation using a GnRH analogue in the standard downregulation arm and 6 weeks of downregulation using a GnRH analogue in the modified downregulation arm.
University College London Hospital
London, NW1 2BU, United Kingdom
Latif S, Wattar BHA, Balachandren N, Lukaszewski T, Saridogan E, Yasmin E, Serhal P, Mavrelos D. 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. BMJ Open. 2021 Oct 29;11(10):e050248. doi: 10.1136/bmjopen-2021-050248.
First Submitted
May 7, 2019
First Posted
May 13, 2019
Study Start
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.
Participant will be offered the opportunity to complete an adenomyosis symptom assessment questionnaire at the start of their treatment, and again two months after completion of treatment.
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August 17, 2020
Primary Completion
August 17, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 17, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 16, 2021
Record last verified: 2021-02
Individual participant data will not be shared outside of the research group.
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Source: ClinicalTrials.gov.
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