A Phase 4 interventional study of GnRH analog (11.25mg Leuprolide acetate) and Aromatase inhibitor and GnRH analog in Uterine Adenomyosis, Recurrent Implantation Failure and Menstrual Pain, sponsored by Centre for Endocrinology and Reproductive Medicine, Italy. Active, not recruiting at 3 sites in 3 countries. Open to female participants aged 30 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Centre for Endocrinology and Reproductive Medicine, Italy · Phase 4, Interventional, and Treatment
With this study the investigators want to test which is the best medical treatment for symptomatic adenomyosis affecting women undergoing IVF and with previous implantation failure, between Aromatase inhibitor plus GnRH analog versus GnRH alone, in term pregnancy rate and uterine volume reduction.
Recently it has been shown that adenomyosis negatively affects the pregnancy rate in IVF cycles. The investigators used in the past for the treatment of other benign gynecological diseases such as endometriosis and uterine myomas a combined therapy with Aromatase inhibitor plus GnRH analog. With this study the investigators want evaluate which is the best way to treat adenomyosis in order to obtain a higher pregnancy rate in women with symptomatic adenomyosis undergoing IVF who failed a previous IVF attempt. For these reasons the investigators set this controlled trial between GnRH analog plus Aromatase Inhibitor (3.75 mg monthly of Leuprolide plus 1.0mg day of Anastrazole for 3 months) versus an active comparator as GnRH analog alone (3.75 mg monthly of Leuprolide for 3 months) after the treatment patients will undergo embryo transfer of a cryopreserved blastocyst in a previous IVF cycle, and will be followed up for uterine dimension reduction and pain symptom reduction.
142 studies on the registry are indexed under Adenomyosis; 54 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 78 interventional studies indexed under Adenomyosis.
Browse Adenomyosis studies →Centre for Endocrinology and Reproductive Medicine, Italy is the lead sponsor of 9 studies on the registry; none are open to participants now.
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control group treated with GnRH analog alone
Drug: GnRH analog (11.25mg Leuprolide acetate)
experimental group treated with aromatase inhibitor plus GnRH analog
Drug: Aromatase inhibitor and GnRH analog · Drug: Aromatase and GnRH analog (11.25mg Leuprolide acetate)
11.25 Leuprolide acetate only one administration
Also known as: Control group
Drug pages: Aromatase inhibitors · Gonadotropin-releasing Hormone Analog
1mg/day of Anastrazole for 3 months
Also known as: experimental group
Drug page: Gonadotropin-releasing Hormone Analog
Leuprolide acetate 11.25mg only one
Also known as: experimental group
This study also gives Anastrozole. No intervention listed here names it: that was found by reading the record.
pregnancy after embryo transfer
after treatment patients undergo embryo transfer of a cryopreservad blastocyst
Time frame: 12 months
uterine volume reduction
differences in uterine volume pre and post treatment evaluated by ultrasound
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2017 (actual). Primary completion is estimated for Sep 2024, 81 months after the start.
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This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Gonadotropin-releasing Hormone Analog · Aromatase inhibitors · Anastrozole
Centre for Endocrinology and Reproductive Medicine, Italy