Natural Cycle Versus Stimulated Cycle Before Frozen Embryo Transfer

NCT02834117 | Completed Phase 4

• 1 other identifier: SONTEC
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Embryo freezing is a technique used regularly to optimize the pregnancy rate in case of infertility. This method is performed in presence of supernumerary embryo(s) after fresh transfer, or after freeze all embryos in case of medical reasons. It is necessary to control that the transfer is performed when the endometrium is receptive, which is essential for embryo implantation and pregnancy. This period is defined as the "implantation window". Endometrial preparation can be achieved by hormone replacement therapy (HRT) or moderate ovarian stimulation (SO). The implantation window can also be assessed by monitoring of a natural cycle (NC). The objectives of this open randomized study is to compare the number of visits (ultrasound and blood tests) induced by the SO or NC as well as the women quality of life in both groups.

Conditions

Fertility

Keywords

Ovulation Induction; quality of life; Reproductive Physiological Processes; fertility

Outcome Measures

Primary Outcomes (1)

• Number of visits

  number of visits (for clinical examination, ultrasound and hormonal dosage) required to monitor ovulation in both groups

  From inclusion visit to embryo transfer : up to 90 days

Secondary Outcomes (10)

• Fertiqol

  From inclusion visit to embryo transfer : up to 90 days

• defrost cancellation rate

  From inclusion visit to embryo transfer : up to 90 days

• transfer on weekends and holidays

  From inclusion visit to embryo transfer : up to 90 days

• HCG levels> 100 U / L

  From inclusion visit to pregnancy test : up to 100 days

• pregnancy

  From pregnancy test to ultrasound at 6 week of gestation : up to 100 days

Study Arms (2)

Natural cycle

OTHER

Ovulation is not induced by drugs

Other: natural cycle

Moderate ovarian stimulation

EXPERIMENTAL

Ovulation is induced by recombinant follitropin alpha and recombinant choriogonadotropin

Drug: moderate ovarian stimulation

Interventions

natural cycle OTHER

Ovulation is not induced by drugs

Also known as: natural

Natural cycle

moderate ovarian stimulation DRUG

Ovulation is induced by recombinant follitropin alpha and recombinant choriogonadotropin

Also known as: ovarian stimulation

Moderate ovarian stimulation

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Affiliation to the general social security regime and benefiting from 100% infertility;
• Regular Cycles 26 to 35 days;
• Support in IVF or ICSI ;
• Existence of at least 2 frozen embryos to J2 or J3;
• Treated for their first or second cycle of TEC.

You may not qualify if:

• Donor sperm;
• Irregular cycles and / or polycystic ovary syndrome;
• Embryos frozen at J1 or J5 / J6 or double planned transfer or transfer of 3 embryos intended;
• Patients who have had more than 3 transfers or more than 6 embryos replaced without pregnancy or puncture rank\> 3;
• uterine malformation existing;
• Presence of a hydrosalpinx.

Sponsors & Collaborators

• Dr Massin Nathalie: lead

Study Sites (1)

CHI Creteil

Créteil, 94000, France

Location

Related Publications (15)

• Bjuresten K, Landgren BM, Hovatta O, Stavreus-Evers A. Luteal phase progesterone increases live birth rate after frozen embryo transfer. Fertil Steril. 2011 Feb;95(2):534-7. doi: 10.1016/j.fertnstert.2010.05.019. Epub 2010 Jun 26.

  PMID: 20579989 BACKGROUND

• Boivin J, Takefman J, Braverman A. The fertility quality of life (FertiQoL) tool: development and general psychometric properties. Hum Reprod. 2011 Aug;26(8):2084-91. doi: 10.1093/humrep/der171. Epub 2011 Jun 10.

  PMID: 21665875 BACKGROUND

• de La Rochebrochard E, Quelen C, Peikrishvili R, Guibert J, Bouyer J. Long-term outcome of parenthood project during in vitro fertilization and after discontinuation of unsuccessful in vitro fertilization. Fertil Steril. 2009 Jul;92(1):149-56. doi: 10.1016/j.fertnstert.2008.05.067. Epub 2008 Aug 15.

  PMID: 18706550 BACKGROUND

• Eftekhar M, Rahmani E, Pourmasumi S. Evaluation of clinical factors influencing pregnancy rate in frozen embryo transfer. Iran J Reprod Med. 2014 Jul;12(7):513-8.

  PMID: 25114675 BACKGROUND

• El Bahja D, Hertz P, Schweitzer T, Lestrade F, Ragage JP. [Frozen embryo transfer protocol: does spontaneous cycle give good results?]. Gynecol Obstet Fertil. 2013 Nov;41(11):648-52. doi: 10.1016/j.gyobfe.2011.08.007. Epub 2012 Feb 16. French.

  PMID: 22342107 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

• 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

• Haouzi D, Assou S, Mahmoud K, Tondeur S, Reme T, Hedon B, De Vos J, Hamamah S. Gene expression profile of human endometrial receptivity: comparison between natural and stimulated cycles for the same patients. Hum Reprod. 2009 Jun;24(6):1436-45. doi: 10.1093/humrep/dep039. Epub 2009 Feb 26.

  PMID: 19246470 BACKGROUND

• Nargund G, Wei CC. Successful planned delay of ovulation for one week with indomethacin. J Assist Reprod Genet. 1996 Sep;13(8):683-4. doi: 10.1007/BF02069650. No abstract available.

  PMID: 8897131 BACKGROUND

• Park SJ, Goldsmith LT, Skurnick JH, Wojtczuk A, Weiss G. Characteristics of the urinary luteinizing hormone surge in young ovulatory women. Fertil Steril. 2007 Sep;88(3):684-90. doi: 10.1016/j.fertnstert.2007.01.045. Epub 2007 Apr 16.

  PMID: 17434509 BACKGROUND

• Tobler KJ, Zhao Y, Weissman A, Majumdar A, Leong M, Shoham Z. Worldwide survey of IVF practices: trigger, retrieval and embryo transfer techniques. Arch Gynecol Obstet. 2014 Sep;290(3):561-8. doi: 10.1007/s00404-014-3232-6. Epub 2014 Apr 18.

  PMID: 24744054 BACKGROUND

• Tomas C, Alsbjerg B, Martikainen H, Humaidan P. Pregnancy loss after frozen-embryo transfer--a comparison of three protocols. Fertil Steril. 2012 Nov;98(5):1165-9. doi: 10.1016/j.fertnstert.2012.07.1058. Epub 2012 Jul 27.

  PMID: 22840239 BACKGROUND

• Troude P, Guibert J, Bouyer J, de La Rochebrochard E; DAIFI Group. Medical factors associated with early IVF discontinuation. Reprod Biomed Online. 2014 Mar;28(3):321-9. doi: 10.1016/j.rbmo.2013.10.018. Epub 2013 Oct 31.

  PMID: 24461478 BACKGROUND

• Weissman A, Levin D, Ravhon A, Eran H, Golan A, Levran D. What is the preferred method for timing natural cycle frozen-thawed embryo transfer? Reprod Biomed Online. 2009 Jul;19(1):66-71. doi: 10.1016/s1472-6483(10)60048-x.

  PMID: 19573293 BACKGROUND

• Yu J, Ma Y, Wu Z, Li Y, Tang L, Li Y, Deng B. Endometrial preparation protocol of the frozen-thawed embryo transfer in patients with polycystic ovary syndrome. Arch Gynecol Obstet. 2015 Jan;291(1):201-11. doi: 10.1007/s00404-014-3396-0. Epub 2014 Jul 31.

  PMID: 25091221 BACKGROUND

MeSH Terms

Interventions

Ovulation Induction

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Nathalie Massin, MD

  CHIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: July 15, 2016
• Study Start: May 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: March 1, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)