Progesterone Supplementation on Women Having Low Progesterone Levels on Transfer Day

NCT04897269 | Unknown Phase 3 DMC

• 1 other identifier: 656/BVTD-HDDD
• Study Type: interventional
• Target: 824
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to compare clinical pregnancy rates between two groups of women who have progesterone levels below 10 ng/mL on the day of frozen embryo transfer: group 1 (vaginal micronized progesterone supplemented with progesterone intramuscular 50 mg per day) and group 2 (vaginal micronized progesterone with no supplementation)

Conditions

Assisted Reproductive Technology

Keywords

low progesterone levels; progesterone supplementation; clinical pregnancy

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  defined as the pregnancy completed 11 - 14 weeks of gestation and having vital fetus

  week 11 - 14 of pregnancy

Secondary Outcomes (3)

• implantation rate

  3 weeks after embryo transfer

• Pregnancy rate

  2 weeks after embryo transfer

• clinical pregnancy rate

  3 weeks after embryo transfer

Study Arms (2)

Control group

NO INTERVENTION

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

Study group

EXPERIMENTAL

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

Procedure: Progesterone supplementation

Interventions

Progesterone supplementation PROCEDURE

This procedure is to add more progesterone on those who have low progesterone levels on the day of embryo transfer

Study group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: We want to investigate on the pregnancy outcome, therefore only female patients will be recruited
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergone ART with frozen embryo transfer, blastocyst or cleavaged stage embryo transfer, from 18-45 years of age
• Normal BMI
• HRT for Endometrial preparation in FET cycles

You may not qualify if:

• Oocyte donor cycles
• 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)

Sponsors & Collaborators

• Tu Du Hospital: lead

Study Sites (1)

Department of Infertility of Tu Du hospital

Ho Chi Minh City, 70000, Vietnam

RECRUITING

Related Publications (5)

• 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.

  PMID: 30642638 RESULT

• 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.

  PMID: 30585507 RESULT

• 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.

  PMID: 29040638 RESULT

• 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.

  PMID: 32043182 RESULT

• 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.

  PMID: 35197354 DERIVED

Study Officials

• Chau TM Le

  Department of Infertility, Tu Du Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chau TM Le, PhD

CONTACT

+84908429006; dr.lethiminhchau@gmail.com

Anh Q Nguyen, Master

CONTACT

+84976137562; dr.anhquocnguyen@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MMSc, PhD, Head of Infertility department of Tu Du hospital

Model Details: Patients who have progesterone levels below 10 ng/mL on the day of embryo transfer will be randomized into 2 groups: 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

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: May 20, 2021
• Primary Completion: May 20, 2024
• Study Completion: June 20, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)