Effect of Intervention on Progesterone Levels Before Euploid Embryo Transfer in Pregnancy Outcomes.
NCT ID: NCT03740568
Last Updated: 2020-07-29
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
598 participants
INTERVENTIONAL
2018-11-15
2020-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Recently several authors have paid attention to serum progesterone (P) as a possible factor influencing Frozen Embryo Transfer (FET) outcomes. P plays an important role in endometrial gland formation, embryonic implantation and pregnancy maintenance. Labarta et al. (2) described in blastocyst FET performed under HRT that serum P \<9.2 ng/mL measured on the transfer day is associated to significantly lower ongoing pregnancy rate (OR 0.297, 95% CI:0.113-0.779).
Recently the investigators have analyzed 244 FEET performed under HRT in a retrospective study (3). Preimplantation genetic testing for aneuploidies (PGT-A) was carried out as previously described (4). Embryos that reached the blastocyst stage were biopsied and frozen immediately afterwards using the vitrification method (5). Euploid embryos were transferred in a subsequent cycle under HRT. Serum P was analyzed the day previous to FEET. Patients with serum P \<10.6 ng/mL had significantly higher miscarriage rate (26.6% vs 9.5%, p=0.007) and lower live birth rate (47.5% vs 62.3 %, p= 0.029) than those with serum P \>10.6 ng/mL. The investigators also observed that patients with serum P \>13.1 ng/mL had the lowest miscarriage rate (9.1%) and the highest live birth rate (65.6%). The worst outcomes were observed when serum P was \<8.06 ng /mL (41% live birth rate and 32.4% miscarriage rate).
As miscarriage was higher among FEET cycles with serum P \<10.6 ng/ml, the investigators hypothesize that altering the progesterone supplementation scheme could potentially reduce miscarriage rates and increase live birth rate. The purpose of this study is to modify the standard progesterone supplementation in FEET under HRT (vaginal micronized progesterone 200 mg every 8 hours) (6) according to serum P measured not only on the day prior to transfer but also on Beta subunit of Human Chorionic Gonadotropin (β-hCG) analysis day, and to probe if this intervention reduces miscarriage rate and increases pregnancy outcome.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer
NCT03395665
Serum Progesterone on the Day of Embryo Transfer and Pregnancy Rate.
NCT03272412
Cut-Off Progesterone Values Deleterious for In Vitro Fertilization and Fresh Embryo Transfer
NCT02323347
Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.
NCT05980091
Optimal Length of Progesterone Supplementation Before the Transfer of Cryopreserved(Frozen)-Thawed Embryos in an Artificial Cycle With Exogenous Estrogen and Progesterone.
NCT02032797
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Normal Progesterone group
Progesterone level \>10.64 ng/mL on day 4 of progesterone supplementation
Normal Progesterone
Same Progesterone supplementation (vaginal micronized P 200mg/200mg/200mg) Warming and transfer on D5
Beta-hCG and P analysis is performed on the 14th day of P supplementation (D14). In case of positive Beta-hCG analysis:
If P is \>10.64 ng /mL: the same P supplementation is continued. If P is \<10.64 ng /mL: an additional dosage of vaginal micronized P (200 mg) is added at night
Low Progesterone group
Progesterone level \<10.64 ng/mL on day 4 of progesterone supplementation
Low Progesterone
Additional daily dosage of subcutaneous progesterone (Psc) 25 mg/day at night since D4 (vaginal micronized P 200mg/200mg/200mg + Psc 25 mg/night) New Progesterone analysis on D5 before warming the embryo. Group 2a (Canceled Group, P on D5 \<10.64 ng/mL): cancel PGT-FET. Scheduling a new procedure under different P supplementation.
Group 2b (Restored Progesterone Group, P on D5 \>10.64 ng/mL): continue HRT as previously described (vaginal micronized P 200mg/200mg/200mg + Psc 25 mg/night). Warming and transfer the same day (D5)
Beta-hCG and P analysis is performed on the 14th day of P supplementation (D14). In case of positive Beta-hCG analysis:
If P is \>10.64 ng /mL: the same P supplementation is continued. If P is \<10.64 ng /mL: an additional dosage of vaginal micronized P (200 mg) is added at night
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Low Progesterone
Additional daily dosage of subcutaneous progesterone (Psc) 25 mg/day at night since D4 (vaginal micronized P 200mg/200mg/200mg + Psc 25 mg/night) New Progesterone analysis on D5 before warming the embryo. Group 2a (Canceled Group, P on D5 \<10.64 ng/mL): cancel PGT-FET. Scheduling a new procedure under different P supplementation.
Group 2b (Restored Progesterone Group, P on D5 \>10.64 ng/mL): continue HRT as previously described (vaginal micronized P 200mg/200mg/200mg + Psc 25 mg/night). Warming and transfer the same day (D5)
Beta-hCG and P analysis is performed on the 14th day of P supplementation (D14). In case of positive Beta-hCG analysis:
If P is \>10.64 ng /mL: the same P supplementation is continued. If P is \<10.64 ng /mL: an additional dosage of vaginal micronized P (200 mg) is added at night
Normal Progesterone
Same Progesterone supplementation (vaginal micronized P 200mg/200mg/200mg) Warming and transfer on D5
Beta-hCG and P analysis is performed on the 14th day of P supplementation (D14). In case of positive Beta-hCG analysis:
If P is \>10.64 ng /mL: the same P supplementation is continued. If P is \<10.64 ng /mL: an additional dosage of vaginal micronized P (200 mg) is added at night
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HRT
* Endometrial thickness \>= 6 mm measured day 4 of progesterone supplementation
Exclusion Criteria
* Uterine abnormality.
* Natural cycle protocol
18 Years
50 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundación Santiago Dexeus Font
OTHER
Dexeus Clinic Woman
OTHER
Fundacion Dexeus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Buenaventura Coroleu
Head Reproductive Service
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bueaventura Coroleu, PhD
Role: STUDY_CHAIR
Hospital Universitari Dexeus. Departamento de Ginecología, Obstetricia y Reproducción
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Departamento Ginecología, Obstetricia y Reproducción . Hospital Universitari Dexeus
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rubio C, Bellver J, Rodrigo L, Castillon G, Guillen A, Vidal C, Giles J, Ferrando M, Cabanillas S, Remohi J, Pellicer A, Simon C. In vitro fertilization with preimplantation genetic diagnosis for aneuploidies in advanced maternal age: a randomized, controlled study. Fertil Steril. 2017 May;107(5):1122-1129. doi: 10.1016/j.fertnstert.2017.03.011. Epub 2017 Apr 19.
Labarta E, Mariani G, Holtmann N, Celada P, Remohi J, Bosch E. Corrigendum: 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. 2018 Jan 1;33(1):178. doi: 10.1093/humrep/dex353. No abstract available.
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.
Coll L, Parriego M, Boada M, Devesa M, Arroyo G, Rodriguez I, Coroleu B, Vidal F, Veiga A. Transition from blastomere to trophectoderm biopsy: comparing two preimplantation genetic testing for aneuploidies strategies. Zygote. 2018 Jun;26(3):191-198. doi: 10.1017/S0967199418000084. Epub 2018 May 25.
Sole M, Santalo J, Boada M, Clua E, Rodriguez I, Martinez F, Coroleu B, Barri PN, Veiga A. How does vitrification affect oocyte viability in oocyte donation cycles? A prospective study to compare outcomes achieved with fresh versus vitrified sibling oocytes. Hum Reprod. 2013 Aug;28(8):2087-92. doi: 10.1093/humrep/det242. Epub 2013 Jun 5.
Martinez F, Boada M, Coroleu B, Clua E, Parera N, Rodriguez I, Barri PN. A prospective trial comparing oocyte donor ovarian response and recipient pregnancy rates between suppression with gonadotrophin-releasing hormone agonist (GnRHa) alone and dual suppression with a contraceptive vaginal ring and GnRH. Hum Reprod. 2006 Aug;21(8):2121-5. doi: 10.1093/humrep/del121. Epub 2006 Apr 21.
Alvarez M, Gaggiotti-Marre S, Martinez F, Coll L, Garcia S, Gonzalez-Foruria I, Rodriguez I, Parriego M, Polyzos NP, Coroleu B. Individualised luteal phase support in artificially prepared frozen embryo transfer cycles based on serum progesterone levels: a prospective cohort study. Hum Reprod. 2021 May 17;36(6):1552-1560. doi: 10.1093/humrep/deab031.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FSD-PRG-2018-09
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.