Two Different Types of Luteal Phase Support in Natural Cycle Frozen Embryo Transfer and Its Effect on Pregnancy Rates

NCT05838105 | Unknown

• 1 other identifier: LutealSupport
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the pregnancy rate between women treated with Gonadotropin Releasing Hormone (GnRH) agonist together with Human Chorionic Gonadotropin (HCG) and standard luteal support with progesterone following transfer of frozen embryos in in-vitro-fertilization (IVF) natural cycles.

Conditions

Luteal Phase Support

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  visualization of intrauterine gestational sac on ultrasound divided by number of transfers

  up to two month after embryo transfer

Secondary Outcomes (5)

• Overall pregnancy rate

  up to two month after embryo transfer

• Implantation rate

  up to two month after embryo transfer

• Ectopic pregnancy rate

  up to two month after embryo transfer

• Miscarriage rate

  up to 20 weeks after embryo transfer

• Live birth rate

  up to 42 weeks after embryo transfer

Study Arms (2)

Study group

ACTIVE COMPARATOR

Patients will receive luteal support with GNRH agonist and HCG according to departmental protocol: Cleavage stage embryo: * ET day (embryo day 2-3) - Ovitrelle 125mcg * Day 3 after ET - Ovitrelle 125mcg + Decapeptyl 0.1mg * Day 6 after ET- Ovitrelle 125mcg * Day 9 after ET - Ovitrelle 125mcg Embryo blastocyst stage: * ET day (embryo day 5-6) - Ovitrelle 125mcg + Decapeptyl 0.1mg * Day 3 after ET - Ovitrelle 125mcg * Day 6 after ET - Ovitrelle 125mcg

Drug: GnRH agonist; Drug: hCG

Control group

ACTIVE COMPARATOR

Patients will receive luteal support with vaginal progesterone - 100 mg Endometrin twice daily until week 8 of pregnancy.

Drug: Progesterone 100Mg Vag Tab

Interventions

GnRH agonist DRUG

125 mcg once at the day mentioned

Study group

hCG DRUG

dose as mentioned

Study group

Progesterone 100Mg Vag Tab DRUG

dose as mentioned

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: patients going in-vitro-fertility treatments with embryo transfer
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normo-ovulatory women
• Women undergoing frozen embryos transfer in a natural cycle
• Age 18-45
• BMI 18-35

You may not qualify if:

• Women undergoing medicated frozen embryos transfer
• Women with a BMI over 35 or under 18.
• Women with hydrosalpinges
• Women with defects or uterine malformations (congenital) or acquired such as myomas
• Egg donation and surrogacy
• Use of preimplantation genetic testing

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek medical center

Jerusalem, 91031, Israel

RECRUITING

Related Publications (8)

• Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2.

  PMID: 23820515 BACKGROUND

• Le Lannou D, Griveau JF, Laurent MC, Gueho A, Veron E, Morcel K. Contribution of embryo cryopreservation to elective single embryo transfer in IVF-ICSI. Reprod Biomed Online. 2006 Sep;13(3):368-75. doi: 10.1016/s1472-6483(10)61441-1.

  PMID: 16984767 BACKGROUND

• Loutradi KE, Kolibianakis EM, Venetis CA, Papanikolaou EG, Pados G, Bontis I, Tarlatzis BC. Cryopreservation of human embryos by vitrification or slow freezing: a systematic review and meta-analysis. Fertil Steril. 2008 Jul;90(1):186-93. doi: 10.1016/j.fertnstert.2007.06.010. Epub 2007 Nov 5.

  PMID: 17980870 BACKGROUND

• Weissman A, Horowitz E, Ravhon A, Steinfeld Z, Mutzafi R, Golan A, Levran D. Spontaneous ovulation versus HCG triggering for timing natural-cycle frozen-thawed embryo transfer: a randomized study. Reprod Biomed Online. 2011 Oct;23(4):484-9. doi: 10.1016/j.rbmo.2011.06.004. Epub 2011 Jun 15.

  PMID: 21840758 BACKGROUND

• Mackens S, Stubbe A, Santos-Ribeiro S, Van Landuyt L, Racca A, Roelens C, Camus M, De Vos M, van de Vijver A, Tournaye H, Blockeel C. To trigger or not to trigger ovulation in a natural cycle for frozen embryo transfer: a randomized controlled trial. Hum Reprod. 2020 May 1;35(5):1073-1081. doi: 10.1093/humrep/deaa026.

  PMID: 32395750 BACKGROUND

• Ghobara T, Gelbaya TA, Ayeleke RO. Cycle regimens for frozen-thawed embryo transfer. Cochrane Database Syst Rev. 2017 Jul 5;7(7):CD003414. doi: 10.1002/14651858.CD003414.pub3.

  PMID: 28675921 BACKGROUND

• Montagut M, Santos-Ribeiro S, De Vos M, Polyzos NP, Drakopoulos P, Mackens S, van de Vijver A, van Landuyt L, Verheyen G, Tournaye H, Blockeel C. Frozen-thawed embryo transfers in natural cycles with spontaneous or induced ovulation: the search for the best protocol continues. Hum Reprod. 2016 Dec;31(12):2803-2810. doi: 10.1093/humrep/dew263. Epub 2016 Oct 25.

  PMID: 27798046 BACKGROUND

• Fatemi HM, Kyrou D, Bourgain C, Van den Abbeel E, Griesinger G, Devroey P. Cryopreserved-thawed human embryo transfer: spontaneous natural cycle is superior to human chorionic gonadotropin-induced natural cycle. Fertil Steril. 2010 Nov;94(6):2054-8. doi: 10.1016/j.fertnstert.2009.11.036. Epub 2010 Jan 25.

  PMID: 20097333 BACKGROUND

MeSH Terms

Interventions

Gonadotropin-Releasing Hormone; Progesterone

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Keren Rotshenker Olshnika, MD

  Sharee Zedek Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heli Alexandroni, MD

CONTACT

+972549900913; heli.alexandroni@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alexandroni Heli

Model Details: All patients will be randomly divided into two groups, each will receive a different luteal treatment: 1. Study group - patients will receive luteal support with GNRH agonist and HCG according to departmental protocol (described later). 2. Control group - patients will receive luteal support with vaginal progesterone.

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 1, 2023
• Study Start: October 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

IL (1)