Effectiveness of progesterone supplementation in women presenting low progesterone levels on the day of frozen embryo transfer: a randomised controlled trial
Introduction Progesterone is an essential hormone involved in the process of implantation and pregnancy maintenance. Evidence from recent studies has supported the importance of serum progesterone level around the time of embryo transfer in hormonal replacement therapy frozen embryo transfer cycles...
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BMJ Publishing Group
2022-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/2/e057353.full |
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| author | Quang Thanh Le Thi Minh Chau Le Khue Tu Duong Quoc Anh Nguyen Phuc Thinh Ong Thi Hong Nhung Nguyen Thi Cam Thu Thai Matheus Roque Carlo Alviggi |
| author_facet | Quang Thanh Le Thi Minh Chau Le Khue Tu Duong Quoc Anh Nguyen Phuc Thinh Ong Thi Hong Nhung Nguyen Thi Cam Thu Thai Matheus Roque Carlo Alviggi |
| author_sort | Quang Thanh Le |
| collection | DOAJ |
| description | Introduction Progesterone is an essential hormone involved in the process of implantation and pregnancy maintenance. Evidence from recent studies has supported the importance of serum progesterone level around the time of embryo transfer in hormonal replacement therapy frozen embryo transfer cycles and recommended the need for individualised luteal support. Low progesterone around the time of embryo transfer is found to be associated with decreased rate of pregnancy after frozen embryo transfer. This single-centre, longitudinal, randomised, interventional controlled study aims to compare the rate of ongoing pregnancy between two groups of women with progesterone level below 10 ng/mL on the day of frozen embryo transfer: the study group using 800 mg vaginal micronised progesterone supplemented with 50 mg intramuscular progesterone per day and the control group using only 800 mg vaginal micronised progesterone.Methods and analysis We enrol patients who are undergoing frozen embryo transfers with blastocyst-stage or cleavage-stage embryos and who satisfy the inclusion and exclusion criteria. After signing the informed consent, participants are randomised into two groups: the study group using vaginal micronised progesterone supplemented with progesterone intramuscular 50 mg per day and the control group using only vaginal micronised progesterone. Randomisation will be performed using R software at a 1:1 allocation ratio. Sequentially numbered, opaque sealed envelopes are used for allocation. The primary outcome is the rate of ongoing pregnancy. To demonstrate a difference of 10% with regard to rate of ongoing pregnancy, at least 370 participants per arm are required (type I error α=0.05, power=0.8). Assuming a dropout rate of 10%, a total of 824 patients (412 per group) will be invited.Ethics and dissemination This study was approved by the Ethics Committee of Tu Du Hospital on 17 May 2021 (reference number: 1251/QĐ-BVTD). All participants provide informed consent before being enrolled in the study. The results of our study will be submitted to reproductive medicine conferences and journals.Trial registration number NCT04897269. |
| format | Article |
| id | doaj-art-dc76403eebcc407ca2376d665d64ee4f |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-dc76403eebcc407ca2376d665d64ee4f2025-02-01T15:35:13ZengBMJ Publishing GroupBMJ Open2044-60552022-02-0112210.1136/bmjopen-2021-057353Effectiveness of progesterone supplementation in women presenting low progesterone levels on the day of frozen embryo transfer: a randomised controlled trialQuang Thanh Le0Thi Minh Chau Le1Khue Tu Duong2Quoc Anh Nguyen3Phuc Thinh Ong4Thi Hong Nhung Nguyen5Thi Cam Thu Thai6Matheus Roque7Carlo Alviggi8Research Unit, Tu Du Hospital, Ho Chi Minh City, Viet NamDepartment of Infertility, Tu Du Hospital, Ho Chi Minh City, Viet NamDepartment of Infertility, Tu Du Hospital, Ho Chi Minh City, Viet NamDepartment of Infertility, Tu Du Hospital, Ho Chi Minh City, Viet NamMathematical Modelling Group, Oxford University Clinical Research Unit, Ho Chi Minh City, Viet NamDepartment of Infertility, Tu Du Hospital, Ho Chi Minh City, Viet NamDepartment of Infertility, Tu Du Hospital, Ho Chi Minh City, Viet NamDepartment of Reproductive Medicine, Mater Prime, São Paulo, BrazilDepartment of Neuroscience, Reproductive Science and Odontostomatology, University of Naples Federico II, Napoli, ItalyIntroduction Progesterone is an essential hormone involved in the process of implantation and pregnancy maintenance. Evidence from recent studies has supported the importance of serum progesterone level around the time of embryo transfer in hormonal replacement therapy frozen embryo transfer cycles and recommended the need for individualised luteal support. Low progesterone around the time of embryo transfer is found to be associated with decreased rate of pregnancy after frozen embryo transfer. This single-centre, longitudinal, randomised, interventional controlled study aims to compare the rate of ongoing pregnancy between two groups of women with progesterone level below 10 ng/mL on the day of frozen embryo transfer: the study group using 800 mg vaginal micronised progesterone supplemented with 50 mg intramuscular progesterone per day and the control group using only 800 mg vaginal micronised progesterone.Methods and analysis We enrol patients who are undergoing frozen embryo transfers with blastocyst-stage or cleavage-stage embryos and who satisfy the inclusion and exclusion criteria. After signing the informed consent, participants are randomised into two groups: the study group using vaginal micronised progesterone supplemented with progesterone intramuscular 50 mg per day and the control group using only vaginal micronised progesterone. Randomisation will be performed using R software at a 1:1 allocation ratio. Sequentially numbered, opaque sealed envelopes are used for allocation. The primary outcome is the rate of ongoing pregnancy. To demonstrate a difference of 10% with regard to rate of ongoing pregnancy, at least 370 participants per arm are required (type I error α=0.05, power=0.8). Assuming a dropout rate of 10%, a total of 824 patients (412 per group) will be invited.Ethics and dissemination This study was approved by the Ethics Committee of Tu Du Hospital on 17 May 2021 (reference number: 1251/QĐ-BVTD). All participants provide informed consent before being enrolled in the study. The results of our study will be submitted to reproductive medicine conferences and journals.Trial registration number NCT04897269.https://bmjopen.bmj.com/content/12/2/e057353.full |
| spellingShingle | Quang Thanh Le Thi Minh Chau Le Khue Tu Duong Quoc Anh Nguyen Phuc Thinh Ong Thi Hong Nhung Nguyen Thi Cam Thu Thai Matheus Roque Carlo Alviggi Effectiveness of progesterone supplementation in women presenting low progesterone levels on the day of frozen embryo transfer: a randomised controlled trial BMJ Open |
| title | Effectiveness of progesterone supplementation in women presenting low progesterone levels on the day of frozen embryo transfer: a randomised controlled trial |
| title_full | Effectiveness of progesterone supplementation in women presenting low progesterone levels on the day of frozen embryo transfer: a randomised controlled trial |
| title_fullStr | Effectiveness of progesterone supplementation in women presenting low progesterone levels on the day of frozen embryo transfer: a randomised controlled trial |
| title_full_unstemmed | Effectiveness of progesterone supplementation in women presenting low progesterone levels on the day of frozen embryo transfer: a randomised controlled trial |
| title_short | Effectiveness of progesterone supplementation in women presenting low progesterone levels on the day of frozen embryo transfer: a randomised controlled trial |
| title_sort | effectiveness of progesterone supplementation in women presenting low progesterone levels on the day of frozen embryo transfer a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/2/e057353.full |
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