Progesterone Supplementation on Women Having Low Progesterone Levels on Transfer Day
NCT ID: NCT04897269
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
824 participants
INTERVENTIONAL
2021-05-20
2024-06-20
Brief Summary
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Detailed Description
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Single center, longitudinal, randomized, interventional, controlled, pharmacological study, enrolling women attending clinical Centers of medically assisted reproduction (ART).
The study protocol consists in the record of all the diagnostic and clinical outcome parameters, according to clinical practice, for the following patient cohorts:
* The patients who are undergoing frozen embryo transfers with blastocyst or cleavage stage embryos and have progesterone levels below 10 ng/mL on the day of embryo transfer
* Study groups
* Group supplemented with progesterone intramuscular 50 mg per day until the day of beta-hcg testing (Intervention group);
* Group with no supplementation (Control group).
* Endometrial cycle is started with estradiol valerate dose of 4 mg to 8 mg per day, the patients then are appointed to have ultrasound scan of their endometrium every 3 to 7 days and the dose of estradiol may be increased to 16 mg per day maximum depends on the thickness of endometrium; when their endometrium reach 8 mm or higher and duration of endometrial preparation is ≥ 12 days, the embryo transfer will be planned and transvaginal progesterone are prescribed according to the day of transfer.
* If this is the first cycle of embryo transfer and she is \< 35 years of age, 1 grade 1 embryo is transferred, otherwise 2 embryos are transferred.
* In the morning of embryo-transferred day, all patients will have their blood tested for progesterone levels, if their levels below 10 ng/mL, they will be recruited into the study and randomized into two groups.
* In the study group, the patients will be prescribed with intramuscular progesterone supplemetation 50 mg + 800mg vaginal micronized progesterone per day for 14 days, until the day of beta-hcg testing.
* In the control group, the patients will continue their regular medications (800mg vaginal micronized progesterone per day) until the day of beta-hcg testing without any progesterone supplementation.
* If the beta-hcg test is positive, the patients will be continued their prescriptions depending on study or control group as mentioned above till 7 weeks of pregnancy when the fetal heart can be confirmed, then the patients will be followed up till 11 - 12 weeks of pregnancy
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
1. Those who will be supplemented with intramuscular progesterone 50mg per day till day of beta-hcg testing
2. Those who will continue their regular medications
TREATMENT
SINGLE
Study Groups
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Control group
In the control group, the patients will be indicated with standard protocol, micronized progesterone (Cyclogest pessary) 400mg two times per day for 14 days, without any progesterone supplementation. If the beta-hcg test is positive, the patients will be treated with the same protocol and followed till 7 weeks of pregnancy when the fetal heart can be confirmed
No interventions assigned to this group
Study group
In the interventional group,the patients will be indicated with standard protocol, micronized progesterone (Cyclogest pessary) 400mg x 2 per day for 14 days, supplemented with intramuscular progesterone (Progesterone 25mg/ml) 25 mg x 2 at one time per day for 14 days. If the beta-hcg test is positive, the patients will be treated with the same protocol and followed till 7 weeks of pregnancy when the fetal heart can be confirmed
Progesterone supplementation
This procedure is to add more progesterone on those who have low progesterone levels on the day of embryo transfer
Interventions
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Progesterone supplementation
This procedure is to add more progesterone on those who have low progesterone levels on the day of embryo transfer
Eligibility Criteria
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Inclusion Criteria
* Normal BMI
* HRT for Endometrial preparation in FET cycles
Exclusion Criteria
* Surrogacy
* IVM
* PGT
* Abnormal Uterine (firbroids 0 -\> 3 according to FIGO classification, polyp, adenomyosis, congenital malformation)
* Uterus fibroids type 4,5 (Figo classification) \> 4cm
* History of recurrent implantation failure
* Endometrial thickness \<7mm on the day of ET
* Cesarean scar defect (isthmocele)
18 Years
45 Years
FEMALE
Yes
Sponsors
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Tu Du Hospital
OTHER_GOV
Responsible Party
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Le Thi Minh Chau
MD, MMSc, PhD, Head of Infertility department of Tu Du hospital
Principal Investigators
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Chau TM Le
Role: PRINCIPAL_INVESTIGATOR
Department of Infertility, Tu Du Hospital
Locations
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Department of Infertility of Tu Du hospital
Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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Chau TM Le, PhD
Role: primary
Anh Q Nguyen, MMSc
Role: backup
References
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Cedrin-Durnerin I, Isnard T, Mahdjoub S, Sonigo C, Seroka A, Comtet M, Herbemont C, Sifer C, Grynberg M. Serum progesterone concentration and live birth rate in frozen-thawed embryo transfers with hormonally prepared endometrium. Reprod Biomed Online. 2019 Mar;38(3):472-480. doi: 10.1016/j.rbmo.2018.11.026. Epub 2019 Jan 5.
Gaggiotti-Marre S, Martinez F, Coll L, Garcia S, Alvarez M, Parriego M, Barri PN, Polyzos N, Coroleu B. Low serum progesterone the day prior to frozen embryo transfer of euploid embryos is associated with significant reduction in live birth rates. Gynecol Endocrinol. 2019 May;35(5):439-442. doi: 10.1080/09513590.2018.1534952. Epub 2018 Dec 26.
Labarta E, Mariani G, Holtmann N, Celada P, Remohi J, Bosch E. Low serum progesterone on the day of embryo transfer is associated with a diminished ongoing pregnancy rate in oocyte donation cycles after artificial endometrial preparation: a prospective study. Hum Reprod. 2017 Dec 1;32(12):2437-2442. doi: 10.1093/humrep/dex316.
Volovsky M, Pakes C, Rozen G, Polyakov A. Do serum progesterone levels on day of embryo transfer influence pregnancy outcomes in artificial frozen-thaw cycles? J Assist Reprod Genet. 2020 May;37(5):1129-1135. doi: 10.1007/s10815-020-01713-w. Epub 2020 Feb 10.
Le TMC, Duong KT, Nguyen QA, Ong PT, Nguyen THN, Thai TCT, Le QT, Roque M, Alviggi C. Effectiveness of progesterone supplementation in women presenting low progesterone levels on the day of frozen embryo transfer: a randomised controlled trial. BMJ Open. 2022 Feb 23;12(2):e057353. doi: 10.1136/bmjopen-2021-057353.
Other Identifiers
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656/BVTD-HDDD
Identifier Type: -
Identifier Source: org_study_id