Progesterone Supplementation on Women Having Low Progesterone Levels on Transfer Day
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Trial Design:
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:
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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
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Study groups
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Group supplemented with progesterone intramuscular 50 mg per day until the day of beta-hcg testing (Intervention group);
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Group with no supplementation (Control group).
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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.
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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.
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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.
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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.
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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.
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: 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 |
|
| Experimental: 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 |
Procedure: Progesterone supplementation
This procedure is to add more progesterone on those who have low progesterone levels on the day of embryo transfer
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Outcome Measures
Primary Outcome Measures
- Ongoing pregnancy rate [week 11 - 14 of pregnancy]
defined as the pregnancy completed 11 - 14 weeks of gestation and having vital fetus
Secondary Outcome Measures
- implantation rate [3 weeks after embryo transfer]
the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period
- Pregnancy rate [2 weeks after embryo transfer]
beta-hCG test is positive
- clinical pregnancy [3 weeks after embryo transfer]
pregnancy when fetal heart can be confirmed
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients undergone ART with frozen embryo transfer, blastocyst or cleavaged stage embryo transfer, from 18-45 years of age
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Normal BMI
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HRT for Endometrial preparation in FET cycles
Exclusion Criteria:
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Oocyte donor cycles
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Surrogacy
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IVM
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PGT
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Abnormal Uterine (firbroids 0 -> 3 according to FIGO classification, polyp, adenomyosis, congenital malformation)
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Uterus fibroids type 4,5 (Figo classification) > 4cm
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History of recurrent implantation failure
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Endometrial thickness <7mm on the day of ET
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Cesarean scar defect (isthmocele)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Infertility of Tu Du hospital | Ho Chi Minh City | Vietnam | 70000 |
Sponsors and Collaborators
- Tu Du Hospital
Investigators
- Principal Investigator: Chau TM Le, Department of Infertility, Tu Du Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 656/BVTD-HDDD