Tamoxifen for Infertility

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of California at San Francisco, San Francisco, CA
Infertility
Tamoxifen - Drug
Eligibility
18 - 65
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a specific medication may help improve the number of eggs that can be retrieved from a woman's ovaries.

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Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether Tamoxifen will improve 1 primary outcome and 9 secondary outcomes in patients with Infertility. Measurement will happen over the course of Up to 2 weeks.

Up to 2 weeks
Compare change in androgen levels during the ovarian stimulation cycle
Compare change in estrogen in follicular fluid
Compare change in estrogen levels during the ovarian stimulation cycle
Compare change in letrozole in follicular fluid
Compare change in progesterone levels during the ovarian stimulation cycle
Compare change in tamoxifen in follicular fluid
Compare duration of stimulation (days) and total gonadotropin dose
Mature Oocyte Yield
Number if competent oocytes on day 3 of embryo culture
Number if competent oocytes on day 5 of embryo culture

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

ER Negative
1 of 3
ER Positive - Tamoxifen
1 of 3
ER Positive - Letrozole
1 of 3
Active Control
Experimental Treatment

This trial requires 144 total participants across 3 different treatment groups

This trial involves 3 different treatments. Tamoxifen is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

ER Positive - Tamoxifen
Drug
ER Positive - Letrozole
Drug
ER Negative
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamoxifen
FDA approved
Letrozole
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 weeks for reporting.

Closest Location

University of California at San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
New breast cancer diagnosis
Has not yet begun chemotherapy
Desires to undergo ovarian stimulation and oocyte retrieval prior to cancer treatment
Age 18 years old or greater

Patient Q&A Section

What is infertility?

"Infertility may be a symptom of a health problem that can be corrected with surgery. About 5% of all couples report that the major problem with their infertility is lack of male/female sexual intercourse.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for infertility?

"Female reproductive medicine involves different treatment options. Female infertility can be treated through gynecological surgery, reproductive endocrinology, or ovarian stimulation (often a combination of these). It's important that men and patients are aware of the risks and benefits of each treatment option before agreeing to treatment.\n" - Anonymous Online Contributor

Unverified Answer

How many people get infertility a year in the United States?

"Around 7 million American women are now having difficulty conceiving. In an effort to improve contraceptive supplies and accessibility, efforts have been made in recent years to increase contraceptive use and educate individuals about contraception. Despite these efforts, rates of use remain low because of the inconvenience and the lack of access to family planning clinics." - Anonymous Online Contributor

Unverified Answer

Can infertility be cured?

"Recent findings provided results that could be helpful to patients with male infertility. For those using the infertility treatments, and those with spontaneous pregnancies, there was no statistically significant difference in the number of pregnancies or the birth rate from the control group. Therefore, the effect of IVF treatment and the pregnancy rate were lower than the fertility clinic where the patients were followed. The only one parameter that was statistically significant was the number of babies born with full-term (more than 37 weeks gestation)." - Anonymous Online Contributor

Unverified Answer

What are the signs of infertility?

"This article examines the signs of infertility in men. A variety of tests can provide the clues that can be used to rule out specific causes. However, for many infertility symptoms there are no known causes. The first step in determining the cause of infertility is to rule out a common cause." - Anonymous Online Contributor

Unverified Answer

What causes infertility?

"A variety of infertility is not linked to a specific cause. Most infertility cases are related to the men, and have a multifactorial cause. Factors such as age, lifestyle, body mass, body image and sexual desire may all play a role in how fertility is affected.\n\nEndometriosis is a chronic inflammatory disorder that arises from a metaplasia of endometrial tissue. Endometriosis usually presents in women in their reproductive years, and rarely affects men.\n\nEndometriosis often presents with vague or non-specific abdominal, painful symptoms that may include pelvic pain, bloating and pelvic or abdominal distention." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of tamoxifen?

"The most common common side effects are breast tenderness (68%), joint pain (62%), headache (56%), and gastrointestinal disorders (53%). Most of these side effects are mild (severity scores 6 and below), but several side effects of tamoxifen are severe in nature, thus warranting immediate medical attention." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in tamoxifen for therapeutic use?

"Tamoxifen has proven to be a successful therapeutic agent for the treatment of ER-positive breast cancer in women; however, additional studies are required to determine the ultimate clinical effectiveness of tamoxifen for the treatment of breast cancer in women of all ages." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for infertility?

"Consideration of clinical endpoints should be provided to all patients who seek fertility treatments. As our present knowledge about the effects of infertility treatments improves, consideration of clinical endpoints should be increased for patients." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of infertility?

"The primary cause of infertility is in many ways an incorrect idea, which is in itself an unwarranted assumption. In this paper, we discuss the reasons for the widespread adoption of such unfounded ideas. We conclude that more serious and comprehensive and more research is needed before settling the question of primary causes of infertility." - Anonymous Online Contributor

Unverified Answer

How serious can infertility be?

"Although there is no good medical reason to refrain from intercourse, the emotional consequences of the news of ininfertility must be a challenge to health professionals. If a man becomes infertile, it means his life and future are put into jeopardy and might jeopardize his partner's as well. The woman may experience similar emotions and this may lead to other problems. It can be very hard to accept that a man can no longer have children of his own." - Anonymous Online Contributor

Unverified Answer

Has tamoxifen proven to be more effective than a placebo?

"We can recommend to treat patients with tamoxifen for a short duration (6 or 12 months) for moderate to pronounced ovarian suppression which was associated with good ovarian response." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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