Infertility Therapy for Women Age Thirty-eight and Older

NCT00246506 | Unknown DMC

• 1 other identifier: 1R01HD044547
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 4

Brief Summary

This study will determine the most effective treatment strategy for infertile couples who present when the female partner is 38 years to the 43rd birthday and the couples are determined to have a reasonable chance for success.

Conditions

Infertility

Keywords

Infertility; Fertility; Reproduction; Advanced Maternal Age; Reproductive Medicine; Reproductive Techniques; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Associated complications of treatment will be described.

  at end of study

Secondary Outcomes (1)

• Demographics and baseline variables will be collected, including: medical and reproductive, history, age, education, income, race, nutritional history, smoking history, and clinical variables related to infertility diagnosis and treatment.

  at end of study

Study Arms (3)

I.

ACTIVE COMPARATOR

Those randomized to have clomiphene/IUI treatments first will initiate therapy with two cycles of the fertility pill called clomiphene combined with (IUI) intrauterine insemination. If not pregnant after 2 IUI cycles, the couples will then proceed to IVF.

Procedure: intrauterine insemination; Procedure: in vitro fertilization

II.

ACTIVE COMPARATOR

Those randomized to have gonadotropins/IUI treatments first will initiate therapy with two cycles of the fertility injections called FSH or gonadotropins combined with (IUI) intrauterine insemination. If not pregnant after 2 IUI cycles, the couples will then proceed to IVF.

Procedure: intrauterine insemination; Procedure: in vitro fertilization

III.

ACTIVE COMPARATOR

Those couples randomized to (IVF) in vitro fertilization will bypass IUI treatments and start IVF therapy immediately.

Procedure: in vitro fertilization

Interventions

intrauterine insemination PROCEDURE

An assisted reproduction technique which deposits washed sperm directly into the uterus, bypassing the cervix, and allowing the sperm to enter the fallopian tubes where fertilization normally occurs.

Also known as: IUI

I.; II.

in vitro fertilization PROCEDURE

This procedure involves stimulating the ovaries, retrieving released eggs, fertilizing the eggs, growing the embryos in a laboratory, and then implanting the embryos in the woman's uterus to develop naturally.

Also known as: assisted reproductive technologies

I.; II.; III.

Eligibility Criteria

• Age: 38 Years - 43 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female partner age from 38th to the 43rd birthday at the time of recruitment and six months of infertility.
• Male partner has a normal semen analysis showing at least 15 million total motile sperm/ejaculate and at least 1% normal forms by strict criteria, or at least 5 million total motile sperm in an IUI prep.
• Patients must have at least one ovary and at least one ipsilateral patent fallopian tube confirmed by HSG or laparoscopy. Pelvic pathology may be present but must be amenable to operative laparoscopy with the pelvis restored to a functional state, including surgically corrected stages I and II endometriosis. Patients with stage III endometriosis qualify only if the disease is limited to an isolated endometrioma in one or both ovaries and once removed the pelvis is restored to a functional state. For patients with a single patent fallopian tube, the open tube cannot have had a previous ectopic (tubal) pregnancy, and the closed tube cannot be a hydrosalpinx (a tube that is blocked at the end and filled with fluid), unless a cauterization has been performed at the junction of the uterus and fallopian tube. Alternatively, that tube could be removed.
• \. Normal uterine cavity demonstrated by HSG, sonohysterogram (SHG), or hysteroscopy; pathology of the uterine cavity amenable to operative hysteroscopy (cavity restored to normal and demonstrated by postoperative study).
• Regular menstrual cycles ranging from 21 - 45 days (patients with occasional cycles, i.e. 1 -2 /year, outside this range will be acceptable).
• Acceptable ovarian reserve demonstrated in all patients by a clomiphene challenge test, i.e., cycle day 3 FSH/E2 values of \<15 mIU/mL and \<100 pg/mL, respectively, and cycle day 10 FSH \< 15 mIU/ml. (Note: normal ovarian reserve is represented by FSH values less than 10-12 mIU/mL; our acceptable values represent the transition zone.) Normal TSH and prolactin levels.
• Informed consent from both partners.
• Female body mass index ≤ 38.

You may not qualify if:

• Previous tubal or uterine cavity reconstructive surgery in which the pelvis or uterine cavity was not restored to functional.
• Unilateral or bilateral hydrosalpinx (a tube that is blocked at the end and filled with fluid) that has not had a cauterization performed at the junction of the uterus and fallopian tubes, or previous removal of a fallopian tube or an ovary.
• A laparoscopy that demonstrated pelvic adhesions or stage I or II endometriosis for which the pelvis could not be restored to normal by surgery, or endometriosis that was not ablated or excised. All patients with stage IV endometriosis, and those with stage III unless the disease is limited to an isolated endometrioma in one or both ovaries and once removed the pelvis is restored to a functional state.
• One or more prior ectopic pregnancies in which both affected tubes were rendered nonfunctional. One ectopic pregnancy if it existed in the single remaining tube. Two or more ectopic pregnancies even if both tubes are patent.
• Severe male factor (i.e. semen analysis not meeting criteria listed above). Couples using donor semen will be excluded
• Previous treatment with IUI or IVF or for normal ovulatory patients with gonadotropins.
• Inadequate ovarian reserve demonstrating FSH 15 mIU/mL or higher on cycle days 3 or 10 or estradiol 100 pg/mL or higher on cycle day 3.
• Anovulatory patients or those whose cycles are routinely \< 21 days or \> 45 days in length.
• Patients requiring gamete intrafallopian tube transfer (GIFT), zygote intrafallopian tube transfer (ZIFT), or tubal embryo transfer (TET).
• BMI greater than 38.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (4)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston IVF

Brookline, Massachusetts, 02446, United States

Location

Boston IVF

Quincy, Massachusetts, 02169, United States

Location

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

Related Publications (3)

• Klipstein S, Regan M, Ryley DA, Goldman MB, Alper MM, Reindollar RH. One last chance for pregnancy: a review of 2,705 in vitro fertilization cycles initiated in women age 40 years and above. Fertil Steril. 2005 Aug;84(2):435-45. doi: 10.1016/j.fertnstert.2005.02.020.

  PMID: 16084887 BACKGROUND

• Nassar KW, Hintzsche JD, Bagby SM, Espinoza V, Langouet-Astrie C, Amato CM, Chimed TS, Fujita M, Robinson W, Tan AC, Schweppe RE. Targeting CDK4/6 Represents a Therapeutic Vulnerability in Acquired BRAF/MEK Inhibitor-Resistant Melanoma. Mol Cancer Ther. 2021 Oct;20(10):2049-2060. doi: 10.1158/1535-7163.MCT-20-1126. Epub 2021 Aug 10.

  PMID: 34376578 DERIVED

• Goldman MB, Thornton KL, Ryley D, Alper MM, Fung JL, Hornstein MD, Reindollar RH. A randomized clinical trial to determine optimal infertility treatment in older couples: the Forty and Over Treatment Trial (FORT-T). Fertil Steril. 2014 Jun;101(6):1574-81.e1-2. doi: 10.1016/j.fertnstert.2014.03.012. Epub 2014 Apr 30.

  PMID: 24796764 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Fertilization in Vitro; Reproductive Techniques, Assisted

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Richard H. Reindollar, M.D.

  Chair, Department of Obstetrics and Gynecology, Dartmouth-Hitchcock Medical Center, Dartmouth Medical School, Lebanon, New Hampshire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2005
• First Posted: October 31, 2005
• Study Start: July 1, 2003
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2013
• Last Updated: January 15, 2013

Record last verified: 2012-12

Locations

US (4)